Advertising |
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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 |
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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 |
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 |
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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 |
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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 |
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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 |
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Multiple Endpoints in Clinical Trials |
Drug Safety |
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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 |
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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 |
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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 |
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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 |
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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) |
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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 |
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Nonclinical Assessment of Investigational Enzyme Replacement Therapy Products |
Procedural |
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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 |