- Emergency Preparedness | Drugs
- Guidance and Other Information of Special Interest to MCM Stakeholders
- Clinical Outcome Assessments (COA) Qualification Submissions
- MCM-Related Guidance by Date
- Activities Report of the Generic Drugs Program (FY 2019) – GDUFA II Quarterly Performance
- Guidance, Compliance, & Regulatory Information
- Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis
- Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry
- Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes Guidance for Industry
- Bispecific Antibody Development Programs Guidance for Industry
- Survey Methodologies to Assess REMS Goals That Relate to Knowledge
- Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications
- ANDA Submissions — Content and Format of Abbreviated New Drug Applications
- Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers
- Physiologically Based Pharmacokinetic Analyses — Format and Content Guidance for Industry
- Osteoarthritis: Structural Endpoints for the Development of Drugs
- Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry
- Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments
- Innovative Approaches for Nonprescription Drug Products
- Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry
- Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry
- Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry
- Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry
- Major Depressive Disorder: Developing Drugs for Treatment
- Patient-Focused Drug Development: Collecting Comprehensive and Representative Input
- Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry
- ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry
- Assessment of Abuse Potential of Drugs
- Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry
- Guidance for Industry 180-Day Exclusivity: Questions and Answers