| CATEGORY -Advertising |
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Brief Summary and Adequate Information for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs |
Considerations for Regulatory Submissions of Promotional Labeling and Advertising Materials including Submissions in Electronic Format |
Direct-to-Consumer Television Advertisements - FDAAA DTC Television Pre-review Program |
Internet/Social Media Platforms with Character Space Limitations: Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices |
Internet/Social Media Platforms: Correcting Independent-Third Party Misinformation About Prescription Drugs and Medical Devices |
Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices - Use of Links |
| CATEGORY - Animal Rule |
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Product Development Under the Animal Rule |
| CATEGORY - Biopharmaceutics |
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Bioavailability and Bioequivalence Studies Submitted in NDA's or INDs for Orally Administered Drug Products - General Considerations |
Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs |
| CATEGORY - Biosimilarity |
|---|
Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 |
Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product |
Considerations in Demonstrating Interchangeability to a Reference Product |
Labeling for Biosimilar Biological Products |
Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act |
| CATEGORY -Chemistry |
|---|
Allowable Excess Volume and Labeled Vial Fill Size |
Analytical Procedures and Methods Validation for Drugs and Biologics |
Appropriate Package Type Terms for Injection Drugs or Biological Products in Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers |
Specified Biotechnology and Specified Synthetic Biological Products - Annual Report |
Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information |
Evaluation of Near Infrared Spectroscopy (NIR) Methods |
Immunogenicity- RelatedConsiderations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs |
Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation |
| CATEGORY -Clinical/Antimicrobial |
|---|
Attachment to Guidance on Antiviral Product Development - Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance Data |
Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment |
Uncomplicated Gonorrhea: Developing Drugs for Treatment |
| CATEGORY -Clinical/Medical |
|---|
Chronic Fatigue Syndrome/Myalgic Enephalomyelitis: Developing Drugs for Treatment |
Common Issues in Drug Development for Rare Diseases |
Developing Drug and Biological Products for Analgesic Indications |
Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS) |
Pregnant Women in Clinical Trials - Scientific and Ethical Considerations |
Standards for Clinical Trial Imaging Endpoints |
Upper Facial Lines: Developing Botulinum Toxin Products |
| CATEGORY -Clinical Pharmacology |
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Clinical Lactation Trials - Trial Design, Data Analysis and Recommendations for Labeling |
General Clinical Pharmacology Considerations for Pediatrics Studies for Drugs and Biological Products |
Pharmacokinetics During Pregnancy and the Postpartum Period - Trial Design, Data Analysis, and Impact on Dosing and Labeling |
| CATEGORY -Clinical/Statistical |
|---|
Multiple Endpoints in Clinical Trials |
| CATEGORY -Quality: Facility, Production and Process Control |
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Contract Manufacturing Arrangements for Drugs: Quality Agreements |
GXP Consideration for Outsourced IT (Cloud Computing) Systems in Medical Product Manufacturing and Clinical Study Environments |
Interim Good Manufacturing Practice for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act |
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice |
Submission of Field Alert Reports and Biological Product Deviation Reports |
| CATEGORY -Drug Safety |
|---|
Best Practices in Developing Proprietary Names |
Content, Format and Submission of Adverse Event Reports by Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act |
Over-the-Counter Pediatric Liquid Drug Products Containing Acetaminophen |
| CATEGORY -Electronic Submissions |
|---|
Providing Regulatory Submissions in Electronic Format - Submissions Under Section 745A of the Federal, Food, Drug and Cosmetic Act |
Providing Regulatory Submissions in Electronic Format - Manufacturing Establishment Information |
Providing Regulatory Submissions in Electronic Format - Postmarketing Safety Reports |
Providing Regulatory Submissions in Electronic Format - Standardized Study Data |
Study Data Technical Conformance Guide and Data Standards Catalog |
| CATEGORY -IND |
|---|
Adverse Events: Collection and Reporting for Secondary Endpoints |
| CATEGORY -Labeling |
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Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products - Content and Format |
Labeling for Human Prescription Drug and Biological Products Approved Under Accelerated Approval |
Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling |
Pregnancy, Lactation, and Females and Males of Reproductive Potential: Labeling for Human Prescription Drug and Biological Products - Content and Format Requirements |
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products - Content and Format |
| CATEGORY -Procedural |
|---|
Applying the Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS) |
Critical Path Innovation Meeting |
Division of Good Clinical Practice Compliance (DGCPC) Requested Contents for New Drug and Biologic Applications to Facilitate BIMO Inspection Planning and Conduct |
Drug Supply Chain Security Act (DSCSA) Implementation: Identification of Suspect Product and Termination of Notifications of Illegitimate Product for Finished Human Prescription Drugs |
DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing of Finished Pharmaceuticals Drugs |
Integrated Summary of Safety |
Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators |
National Drug Code (NDC) Assignment of CDER-Regulated Products |
Public Disclosure of FDA-Sponsored Studies |
Reporting Drug Sample Distribution Under Section 6004 of the Affordable Care Act |
Reporting Licensure by Wholesale Drug Distributor and Third-Party Logistic Providers |
Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs |
Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge |
Use of a Master File for Shared System Risk Evaluation and Mitigation Strategies |
User Fees for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal, Food, Drug and Cosmetic Act |