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Cato Research Blog » Expertise and Research in Drug Development - Clinical and Regulatory through Approval
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fda.gov/regulatory-information/search-fda-guidance-documents... | Guidance for Industry: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Custo... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Submission of Plans for Cigarette Packages and Cigarette Advertisements |
fda.gov/regulatory-information/search-fda-guidance-documents... | Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of th... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Requesting FDA Feedback on Combination Products : Draft Guidance for Industry and FDA Staff |
fda.gov/regulatory-information/search-fda-guidance-documents... | Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for I... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review: Guidance for Industry; Technical Speci... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Considerations for the Development of Dried Plasma Products Intended for Transfusion: Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for M... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Acceptance and Filing Reviews for Premarket Approval Applications (PMAs): Guidance for Industry and Food and Drug Administrat... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Annual Reports for Approved Premarket Approval Applications (PMA) : Guidance for Industry and Food and Drug Administration St... |
fda.gov/regulatory-information/search-fda-guidance-documents... | eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff |
fda.gov/regulatory-information/search-fda-guidance-documents... | FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guida... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Guidance for Industry: Nutrition and Supplement Facts Labels Questions and Answers Related to the Compliance Date, Added Suga... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Real-Time Premarket Approval Application (PMA) Supplements: Guidance for Industry and FDA Staff |
fda.gov/regulatory-information/search-fda-guidance-documents... | Chapter 2 – Biologics |
fda.gov/regulatory-information/search-fda-guidance-documents... | Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff |
fda.gov/regulatory-information/search-fda-guidance-documents... | FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or E... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment Guidance for Industry... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products |
fda.gov/regulatory-information/search-fda-guidance-documents... | Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products: Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Certificates of Confidentiality: Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug... |
fda.gov/regulatory-information/search-fda-guidance-documents... | CVM GFI #256 – Compounding Animal Drugs from Bulk Drug Substances |
fda.gov/regulatory-information/search-fda-guidance-documents... | Transdermal and Topical Delivery Systems – Product Development and Quality Considerations |
fda.gov/regulatory-information/search-fda-guidance-documents... | Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and... |
fda.gov/advisory-committees/advisory-committee-calendar/janu... | January 14, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Ri... |
fda.gov/advisory-committees/advisory-committee-calendar/janu... | January 15, 2020 Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Ri... |
fda.gov/advisory-committees/january-16-2020-meeting-anesthet... | January 16, 2020: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement – 01/16/20... |
canada.ca/en/health-canada/services/drugs-health-products/me... | https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/what-new.html |
canada.ca/en/health-canada/services/drugs-health-products/na... | https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/what-new.html |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Notice – Update to Clinical Trial Site Information Form |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Notice – Submitting Master File Transactions via the Common Electronic Submissions Gateway (CEGS) |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/instruments-medicaux/quoi-neuf.html |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Avis – Mise à jour du formulaire d’information sur le lieu de l’essai clinique |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Avis – Soumission de transactions de fiches maîtresses par l’entremise du Portail commun de demandes électroniques (PDCE) |
fda.gov/media/72646/download | The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff |
fda.gov/regulatory-information/search-fda-guidance-documents... | Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices |
fda.gov/regulatory-information/search-fda-guidance-documents... | Standards Development and the Use of Standards in Regulatory Submissions Reviewed in CBER |
fda.gov/regulatory-information/search-fda-guidance-documents... | Refuse to Accept Policy for 510(k)s |
fda.gov/regulatory-information/search-fda-guidance-documents... | Format for Traditional and Abbreviated 510(k)s |
fda.gov/media/102699/download | Medical Device User Fee Amendments |
fda.gov/regulatory-information/search-fda-guidance-documents... | Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 |
fda.gov/regulatory-information/search-fda-guidance-documents... | Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Electronic Submission of IND Safety Reports Technical Conformance Guide : Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Providing Regulatory Submissions in Electronic Format: IND Safety Reports: Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Indus... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Breast Implants – Certain Labeling Recommendations to Improve Patient Communication: Draft Draft Guidance for Industry and F... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry: Draft Revised Draft |
fda.gov/regulatory-information/search-fda-guidance-documents... | Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Gu... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers |
fda.gov/regulatory-information/search-fda-guidance-documents... | Drug Master Files Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling: Guidance for Industry and F... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations: Guidance for Indust... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination Guidanc... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus: Guida... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment: Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Ava... |
fda.gov/advisory-committees/advisory-committee-calendar/nove... | November 6-7, 2019: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting Announceme... |
fda.gov/advisory-committees/advisory-committee-calendar/vacc... | Vaccines and Related Biological Products Advisory Committee November 8, 2019 Meeting Announcement – 11/08/2019 – 11/08/2019 |
fda.gov/advisory-committees/advisory-committee-calendar/nove... | November 13, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting |
fda.gov/advisory-committees/advisory-committee-calendar/nove... | November 13-14, 2019: Immunology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement |
fda.gov/advisory-committees/november-14-2019-meeting-endocri... | November 14, 2019: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement |
fda.gov/advisory-committees/blood-products-advisory-committe... | Blood Products Advisory Committee November 22, 2019 Meeting |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Updated notice: Mandatory Use of the Electronic Common Technical Guidance (eCTD) Format |
canada.ca/en/health-canada/services/drugs-health-products/dr... | REP information page |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Notice: Regulatory Enrolment Process (REP) Pilot for Clinical Trials |
canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_form... | Master File (MF) Application Fee Form for Human Drugs |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Release of the revised Guidance Document: Post-Notice of Compliance (NOC) Changes – Safety and Efficacy |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Revisions to the Guidance Document: Questions & Answers: Plain Language Labelling Regulations for Prescription Drugs |
canada.ca/en/health-canada/services/drugs-health-products/pu... | Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on the International Council ... |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Avis mise à jour : Utilisation obligatoire du format Electronic Common Technical Document (eCTD) |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | page d’informations REP |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Avis : Projet pilote relatif au processus d’inscription réglementaire (PIR) pour les essais cliniques |
canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_form... | Formulaire sur les frais pour Fiche maîtresse pour les médicaments à usage humain |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Publication de la Ligne directrice : Changements survenus après l’avis de conformité (AC) : Document sur l’innocuité et l’ef... |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Modifications apportées la ligne directrice : Question et réponses : Le règlement sur l’étiquetage en langage clair pour les... |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Avis : Consultation publique conjointe entre Santé Canada et de la Food and Drug Administration des États Unis sur les ligne... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Patient-Focused Drug Development: Methods to Identify What Is Important to Patients |
fda.gov/regulatory-information/search-fda-guidance-documents... | Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act |
fda.gov/regulatory-information/search-fda-guidance-documents... | Clinical Decision Support Software |
fda.gov/regulatory-information/search-fda-guidance-documents... | General Wellness: Policy for Low Risk Devices |
fda.gov/regulatory-information/search-fda-guidance-documents... | Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices |
fda.gov/regulatory-information/search-fda-guidance-documents... | Off-The-Shelf Software Use in Medical Devices |
fda.gov/regulatory-information/search-fda-guidance-documents... | Policy for Device Software Functions and Mobile Medical Applications |
fda.gov/regulatory-information/search-fda-guidance-documents... | Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations |
fda.gov/regulatory-information/search-fda-guidance-documents... | Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment |
fda.gov/regulatory-information/search-fda-guidance-documents... | The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program |
fda.gov/regulatory-information/search-fda-guidance-documents... | Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy |
fda.gov/regulatory-information/search-fda-guidance-documents... | Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway |
fda.gov/regulatory-information/search-fda-guidance-documents... | Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway |
fda.gov/regulatory-information/search-fda-guidance-documents... | Interacting with the FDA on Complex Innovative Trial Designs for Drugs and Biological Products |
fda.gov/regulatory-information/search-fda-guidance-documents... | Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway |
fda.gov/regulatory-information/search-fda-guidance-documents... | Safety and Performance Based Pathway |
fda.gov/regulatory-information/search-fda-guidance-documents... | Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway |
fda.gov/regulatory-information/search-fda-guidance-documents... | Safer Technologies Program for Medical Devices |
fda.gov/regulatory-information/search-fda-guidance-documents... | Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act |
fda.gov/regulatory-information/search-fda-guidance-documents... | The Abbreviated 510(k) Program |
fda.gov/regulatory-information/search-fda-guidance-documents... | The Special 510(k) Program |
fda.gov/regulatory-information/search-fda-guidance-documents... | Acceptance Review for De Novo Classification Requests |
fda.gov/regulatory-information/search-fda-guidance-documents... | FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals |
fda.gov/regulatory-information/search-fda-guidance-documents... | User Fees and Refunds for De Novo Classification Requests |
fda.gov/regulatory-information/search-fda-guidance-documents... | Humanitarian Device Exemption (HDE) Program |
fda.gov/regulatory-information/search-fda-guidance-documents... | Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 2 Years of A... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Humanitarian Use Device (HUD) Designations |
fda.gov/regulatory-information/search-fda-guidance-documents... | Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers |
fda.gov/advisory-committees/advisory-committee-calendar/vacc... | Vaccines and Related Biological Products Advisory Committee October 9, 2019 Meeting Announcement – 10/09/2019 – 10/09/2019 |
fda.gov/advisory-committees/advisory-committee-calendar/octo... | October 16, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement – 10/16/2019 – 10/16/2019 |
fda.gov/advisory-committees/advisory-committee-calendar/octo... | October 29, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement |
fda.gov/advisory-committees/advisory-committee-calendar/octo... | October 30, 2019: Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee Meeting Announcement – 10/30/2019 – 10... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classification... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications: Gu... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Guidance for Industry: Policy Related to Cranberry Products with Added Flavorings |
fda.gov/regulatory-information/search-fda-guidance-documents... | Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Male Breast Cancer: Developing Drugs for Treatment: Draft Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | CVM GFI #257 (VICH GL57) Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: ... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Guidance for Industry: Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement ... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Osteoporosis: Nonclinical Evaluation of Drugs Intended for Treatment Guidance for Industry: Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Fabry Disease: Developing Drugs for Treatment Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirement... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Draft Guidance for Industry and Food... |
fda.gov/regulatory-information/search-fda-guidance-documents... | “Harmful and Potentially Harmful Constituents” in Tobacco Products as Used in Section 904(e) of the Federal Food, Drug, and Cosm... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES |
fda.gov/regulatory-information/search-fda-guidance-documents... | General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers |
fda.gov/regulatory-information/search-fda-guidance-documents... | Uncomplicated Urinary Tract Infections: Developing Drugs for Treatment Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Vulvovaginal Candidiasis: Developing Drugs for Treatment |
fda.gov/regulatory-information/search-fda-guidance-documents... | Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administr... |
fda.gov/regulatory-information/search-fda-guidance-documents... | CVM GFI #181 Blue Bird Medicated Feed Labels |
fda.gov/regulatory-information/search-fda-guidance-documents... | Providing Regulatory Submissions in Electronic Format–Submission of Manufacturing Establishment Information Guidance for Industr... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Postmarketing Safety Reporting for Combination Products: Guidance for Industry and FDA Staff |
fda.gov/regulatory-information/search-fda-guidance-documents... | Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications ... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry: Draft Clinical/Medical |
fda.gov/regulatory-information/search-fda-guidance-documents... | Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submission... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Guidance for Institutional Review Boards,... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Population Pharmacokinetics |
fda.gov/regulatory-information/search-fda-guidance-documents... | Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Using the Inactive Ingredient Database Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) D... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Center for Devices and Radiological Health (CDRH) Appeals Processes: Guidance for Industry and Food and Drug Administration Staf... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A: Guidance for Industry and... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance ... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device ... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Marketing Clearance of Diagnostic Ultrasound Systems and Transducers : Guidance for Industry and Food and Drug Administration St... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Clinical Investigations for Prostate Tissue Ablation Devices: Draft Guidance for Industry and Food and Drug Administration Staff |
fda.gov/regulatory-information/search-fda-guidance-documents... | E19 OPTIMISATION OF SAFETY DATA COLLECTION |
fda.gov/regulatory-information/search-fda-guidance-documents... | M10 BIOANALYTICAL METHOD VALIDATION |
fda.gov/regulatory-information/search-fda-guidance-documents... | Draft Guidance for Industry: Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting |
fda.gov/regulatory-information/search-fda-guidance-documents... | Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Huma... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507 |
fda.gov/regulatory-information/search-fda-guidance-documents... | Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Mouse Embryo Assay for Assisted Reproduction Technology Devices |
fda.gov/regulatory-information/search-fda-guidance-documents... | Testing for Biotin Interference in In Vitro Diagnostic Devices: Draft Draft Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Applications for Premarket Review of New Tobacco Products |
fda.gov/regulatory-information/search-fda-guidance-documents... | Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance f... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Draft Guidance for Industry: Evaluating Alternate Curricula for the Standards for the Growing, Harvesting, Packing, and Holding ... |
fda.gov/regulatory-information/search-fda-guidance-documents... | CPG Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) |
fda.gov/advisory-committees/advisory-committee-calendar/sept... | September 27, 2019: Meeting of the Pediatric and Drug Safety and Risk Management Committees – 09/27/2019 – 09/27/2019 |
fda.gov/advisory-committees/advisory-committee-calendar/sept... | September 26, 2019: Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees – 09/26/2019 – 09/26/2019 |
fda.gov/advisory-committees/advisory-committee-calendar/sept... | September 18, 2019: Meeting of the Nonprescription Drugs Advisory Committee Meeting Announcement – 09/18/2019 – 09/18/2019 |
fda.gov/advisory-committees/blood-vaccines-and-other-biologi... | Allergenic Products Advisory Committee September 13, 2019 Meeting Announcement – 09/13/2019 – 09/13/2019 |
fda.gov/advisory-committees/patient-engagement-advisory-comm... | September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement – 09/10/2019 – 09/10/2019 |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Notice: Revisions to the Guidance Document: Administrative Processing of Submissions and Applications Involving Human or Disinfe... |
hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php | http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-eng.php |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Release of the revised Post-Notice of Compliance (NOC) Changes – Quality Guidance |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Release of the revised Notice regarding the Post-Notice of Compliance (NOC) Changes- Notices of Change: Level III Form |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Revisions to the Guidance Document: Management of Drug Submissions and Applications |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Organisation and Document Placement for Canadian Module 1 of the Common Technical Document (CTD) Structure |
canada.ca/en/health-canada/services/drugs-health-products/pu... | Consultation portant sur : L’ébauche de la ligne directrice: Guide de mise en œuvre technique du module 1 canadien pour le forma... |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Notice – New regulatory activity types for filing to the Marketed Health Products Directorate (MHPD) |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Notice – Regulatory Enrolment Process (REP) implementation and expansion of the scope for the Common Electronic Submissions Gate... |
canada.ca/en/health-canada/services/drugs-health-products/me... | Update Noticed: Introduction of the Regulatory Enrolment Process (REP) and the Use of the Common Electronic Submission Gateway (... |
canada.ca/en/health-canada/services/drugs-health-products/dr... | Updated Product Monograph Template – Schedule D and Schedule D Biosimilar Biologic Drug |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Avis : Révisions du Ligne Directrice: Traitement administratif des présentations et des demandes concernant les médicaments dest... |
hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-fra.php | http://www.hc-sc.gc.ca/dhp-mps/brgtherap/update-miseajour/index-fra.php |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/naturels-sans-ordonnance/quoi-de-neuf.html |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Publication de la version révisée de la Ligne directrice: Changements survenus après l’avis de conformité (AC) : Document sur la... |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Révision du Formulaire de déclaration de changements de niveau III de Santé Canada : Changements survenus après l’avis de confor... |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Révisions à la ligne directrice : Gestion des présentations et des demandes de drogues |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Organisation et emplacement des documents pour le module 1 canadien de la structure Common Technical Document (CTD) |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Avis – Nouveaux types d’activité de réglementation à présenter à la Direction des produits de santé commercialisés (DPSC) |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Avis – Mise en œuvre du Processus d’inscription réglementaire (PIR) et expansion du portail commun de demandes électroniques (PC... |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Mise à jour Avis : Implantation du processus d’inscription réglementaire (PIR) et de l’utilisation du portail commun de demandes... |
canada.ca/fr/sante-canada/services/medicaments-produits-sant... | Mise à jour le Modèle de monographie de produit – Annexe D et Annexe D médicament biologique biosimilaire |
accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?C... | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=801 |
accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?C... | https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=809 |
gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Presc... | TANZEUM prescribing information, medication guide, and instructions for use label. |
janssenlabels.com/package-insert/product-instructions-for-us... | Instructions for Use SPRAVATO. |
pi.lilly.com/ca/taltz-pfs-ca-ifu.pdf | Instructions for Use TALTZ |
accessdata.fda.gov/drugsatfda_docs/label/2010/procrit-epogen... | Instructions for Use PROCRIT. |
pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/repa... | Instructions for Use Repatha. |
fda.gov/regulatory-information/search-fda-guidance-documents... | Formal Dispute Resolution: Sponsor Appeals Above the Division Level Guidance for Industry and Review Staff |
fda.gov/regulatory-information/search-fda-guidance-documents... | Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;: Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guida... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Draft Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling |
fda.gov/regulatory-information/search-fda-guidance-documents... | Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Determining Whether to Submit an ANDA or a 505(b)(2) Application |
fda.gov/regulatory-information/search-fda-guidance-documents... | Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-The -Counter Monograph: ... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry: Guidance for Industr... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis: Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57): Guidance for Industry and Food an... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Clinical Lactation Studies: Considerations for Study Design |
fda.gov/regulatory-information/search-fda-guidance-documents... | Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56): Guidance for Industry and ... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Medical X-Ray Imaging Devices Conformance with IEC Standards: Guidance for Industry and Food and Drug Administration Staff |
fda.gov/regulatory-information/search-fda-guidance-documents... | Policy Clarification for Certain Fluoroscopic Equipment Requirements: Guidance for Industry and Food and Drug Administration Sta... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Postapproval Pregnancy Safety Studies Guidance for Industry |
fda.gov/regulatory-information/search-fda-guidance-documents... | Submitting Documents Utilizing Real-World Data and Real-World Evidence to FDA for Drugs and Biologics |
fda.gov/regulatory-information/search-fda-guidance-documents... | Utilizing Animal Studies to Evaluate Organ Preservation Devices: Guidance for Industry and Food and Drug Administration Staff |
fda.gov/regulatory-information/search-fda-guidance-documents... | Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and ... |
fda.gov/regulatory-information/search-fda-guidance-documents... | Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for Industry |
fda.gov/advisory-committees/advisory-committee-calendar/may-... | May 14, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement |
fda.gov/advisory-committees/advisory-committee-calendar/may-... | May 30-31, 2019: General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement |
fda.gov/advisory-committees/advisory-committee-calendar/june... | June 6, 2019: Antimicrobial Drugs Advisory Committee Meeting Announcement |
fda.gov/advisory-committees/advisory-committee-calendar/june... | June 11-12, 2019: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug ... |
fda.gov/advisory-committees/advisory-committee-calendar/june... | June 19-20, 2019: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement |
fda.gov/advisory-committees/advisory-committee-calendar/june... | June 20, 2019: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee |
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