| Advertising |
|---|
| Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs |
| Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs |
| Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act |
| Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites |
| Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products |
| Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs |
| Biopharmaceutics |
|---|
| 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 |
| Food Effects Bioavailability and Fed Bioequivalence Studies |
| Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System |
| Biosimilarity |
|---|
| Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 |
| Considerations in Demonstrating Interchangeability to a Reference Product Labeling for Biosimilar Biological Products |
| Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity |
| Clinical/Medical |
|---|
| Alcoholism: Developing Drugs for Treatment |
| Common Issues in Drug Development for Rare Diseases |
| Duchenne Muscular Dystrophy and Related Dystorphinopaties: Developing Drugs for Treatment |
| Evaluating Drug Effects on Ability to Operate a Motor Vehicle |
| Exocrine Pancreatic Insufficiency Drug Products: Submitting Marketing Applications and Recommendations for Labeling |
| Head Lice Infestations: Developing Drugs for Treatment |
| Measuring Treatment Benefit in Pediatric Populations: Use of Clinical Outcome Assessments |
| Pregnant Women in Clinical Trials – Scientific and Ethical Considerations |
| Standards for Clinical Trial Imaging Endpoints |
| Sunscreens: Safety and Effectiveness Data for Over-the-Counter Monograph Active Ingredients |
| Ulcerative Colitis: Developing Drugs for Treatment |
| Clinical Pharmacology |
|---|
| Clinical Lactation Trials – Trial Design, Data Analysis and Recommendations for Labeling |
| Content and Format of the Clinical Pharmacology Section of a New Drug Applications (NDA) and Biologics License Applications (BLA) |
| Dose Selection in Drug Development |
| Exposure-Response Relationships |
| In vitro Drug Interactions |
| In vivo Drug Interactions |
| Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis and Impact on Dosing and Labeling |
| Pharmacokinetics During Pregnancy and the Postpartum Period – Trial Design, Data Analysis, and Impact on Dosing and Labeling |
| Population Pharmacokinetics |
| Clinical/Statistical |
|---|
| Multiple Endpoints in Clinical Trials |
| Drug Safety |
|---|
| 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 |
| Modifications and Revisions of Risk Evaluation and Mitigation Strategies (REMS) |
| Safety Assessment for Expedited Reporting for IND Studies |
| Electronic Submissions |
|---|
| NDA and BLA Content for Planning and Conduct of Bioresearch Monitoring Inspections (BIMO) for CDER Submissions |
| Providing Regulatory Submissions in Electronic Format – Manufacturing Establishment Information |
| Providing Regulatory Submissions in Electronic Format – Bioanalytical Methods Data Standards |
| Generics |
|---|
| Acceptability of Draft Package Insert Labeling to Support ANDA Approval |
| ANDA Submissions Refuse-to-Receive for Typographical Errors and Misplaced Files |
| Complete Assessments for Type II API DMFs Under GDUFA |
| Guidance for Industry on GDUFA Completeness Assessment Checklist for Type II API DMFs |
| Labeling |
|---|
| Indications and Usage Section of Labeling for Human Prescription Drugs and Biological Products – Content and Format |
| Pediatric Information: Incorporating into Human Prescription Drug and Biological Products Labeling |
| Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products – Content and Format |
| Pharmaceutical Quality/CMC |
|---|
| Advancement of Emerging Technology Applications to Modernize the Pharmaceutical Manufacturing Base |
| Appropriate Package Type Terms for Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use |
| Botanical Drug Development |
| Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information |
| Development of Near Infrared Spectroscopy (NIR) Procedures |
| Drug Products Containing Nanomaterials |
| Elemental Impurities in Drug Products Marketed in the United States |
| Environmental Assessment: Questions and Answers Regarding Drugs with Hormonal Activity |
| Established Conditions: Reportable CMC Changes for Approved Drugs and Biologic Products |
| Liposome Drug Products: CMC, Human Pharmacokinetic and Bioavailability; and Labeling Documentation |
| Microbiological Quality Consideration in Non-sterile Drug Product Manufacturing |
| Quality Metrics and Risk-Based Inspections |
| Specified Biotechnology and Specified Synthetic Biological Products – Annual Report |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) |
|---|
| CGMP Data Integrity Questions and Answers |
| Current Good Manufacturing Practice for Outsourcing Facilities (Pharmacy Compounding) |
| Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities |
| CATEGORY – Pharmacology/Toxicology |
|---|
| Nonclinical Assessment of Investigational Enzyme Replacement Therapy Products |
| Procedural |
|---|
| Applying the Statutory Criteria for Requiring a Risk Evaluation and Mitigation Strategy (REMS) |
| Compliance Policy Guide: Marketed Unapproved Drugs Section 440.100; Revised Draft |
| Critical Path Innovation Meeting |
| DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers |
| DSCSA Implementation: Products Eligible for Grandfather Status |
| DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices |
| DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs |
| DSCSA: Verification Systems for Prescription Drugs |
| DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements |
| For Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B |
| Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products |
| Information on How to Apply for a CDER Certification of Pharmaceutical Product (CPP) Export Certificate |
| Investigational New Drug Applications Prepared and Submitted by Clinical Sponsor Investigators |
| Mixing, Diluting or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application |
| National Drug Code (NDC) Assignment of CDER-Regulated Products |
| Nonprescription Sunscreen Drug Products – Content and Format of Data Submissions to Support a GRASE Determination Under the Sunscreen Innovation Act |
| Process for Withdrawal of GRASE Request or Pending Request Under the Sunscreen Innovation Act |
| Public Disclosure of FDA-Sponsored Studies |
| REMS Program Evaluation: Assessment Planning and Reporting |
| Special Protocol Assessment |
| Submission of Field Alert Reports and Biological Product Deviation Reports |
| Submission of Study Protocols for Drug Products with Certain Risk Evaluation and Mitigation Strategies for Review by the Office of Generic Drugs |
| Sunscreen Innovation Act Review Process, Including Section 586C(c) |
| Survey Methodologies to Assess Risk Evaluation and Mitigation Strategies (REMS) Goal Related to Knowledge |
| Use of a Drug Master File for Shared System Risk Evaluation and Mitigation Strategies (REMS) |
| Use of Electronic Informed Consent in Clinical Investigations Questions and Answers |