| Clinical - Medical | Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction | Draft | 1/7/2025 |
| Clinical/Medical | Developing Drugs for Optical Imaging | Draft | 1/7/2025 |
| Clinical/Medical | Study of Sex Differences in the Clinical Evaluation of Medical Products | Draft | 1/6/2025 |
| Compounding and Related Documents | Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act | Final | 1/6/2025 |
| Compounding and Related Documents | Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act | Final | 1/6/2025 |
| Artificial Intelligence | Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products | Draft | 1/7/2025 |
| Administrative/Procedural | Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers | Draft | 1/6/2025 |
| Pharmaceutical Quality Current Good Manufacturing Practice (CGMP) | Considerations for Complying with 21 CFR 211.110 | Draft | 1/6/2025 |
| Pharmaceutical Quality, Chemistry, Manufacturing, and Controls (CMC) | Advanced Manufacturing Technologies Designation Program | Final | 12/31/2024 |
| ICH - Multidisciplinary | M15 General Principles for Model-Informed Drug Development | Draft | 12/30/2024 |
| ICH - Efficacy | E11A Pediatric Extrapolation | Final | 12/30/2024 |
| ICH - Efficacy | E6(R3) Good Clinical Practice: Annex 2 | Draft | 12/30/2024 |
| Clinical - Medical | Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices | Draft | 12/30/2024 |
| Technical Specifications Document | Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH)\ | Final | 12/13/2024 |
| Procedural | Accelerated Approval – Expedited Program for Serious Conditions | Draft | 12/5/2024 |
| ICH - Multidisciplinary | M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms | Final | 10/30/2024 |
| Labeling / Clinical Pharmacology | Drug Interaction Information in Human Prescription Drug and Biological Product Labeling | Draft | 10/21/2024 |
| Clinical - Medical | Postoperative Nausea and Vomiting: Developing Drugs for Prevention | Draft | 10/17/2024 |
| User Fees | Requests for Reconsideration at the Division Level Under GDUFA | Final | 10/16/2024 |
| Compounding | Temporary Policies for Compounding Certain Parenteral Drug Products | Final | 10/11/2024 |
| Administrative / Procedural | Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers | Final | 10/1/2024 |
| Clinical - Medical | Conducting Clinical Trials With Decentralized Elements | Final | 9/17/2024 |
| Real World Data / Real World Evidence (RWD/RWE) | Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice | Draft | 9/17/2024 |
| Electronic Submissions | Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry | Final | 9/11/2024 |
| Generic Drugs | ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA | Final | 9/11/2024 |
| Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality | Control of Nitrosamine Impurities in Human Drugs | Final | 9/5/2024 |
| ICH - Multidisciplinary | M12 Drug Interaction Studies: Questions and Answers | Final | 8/2/2024 |
| Electronic Submissions | Providing Over-the-Counter Monograph Submissions in Electronic Format | Final | 7/25/2024 |
| Real World Data / Real World Evidence (RWD/RWE) | Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products | Final | 7/25/2024 |
| Biologics | Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers | Draft | 7/23/2024 |
| Clinical - Medical | Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment | Draft | 7/19/2024 |
| Clinical - Pharmacology | Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies | Final | 7/18/2024 |
| Clinical - Pharmacology | Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older Guidance for Industry | Final | 7/15/2024 |
| Combination Products | Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products | Draft | 7/08/2024 |
| ICH - Multidisciplinary | M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines | Draft | 7/05/2024 |
| Biosimilars | Considerations in Demonstrating Interchangeability With a Reference Product: Update | Draft | 6/21/2024 |
| Generic Drugs | Facility Readiness: Goal Date Decisions Under GDUFA | Final | 6/18/2024 |
| Clinical/Antimicrobial | Diabetic Foot Infections: Developing Drugs for Treatment | Final | 6/17/2024 |
| Clinical - Medical | Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics | Final | 6/14/2024 |
| Safety - Issues, Errors, and Problems | REMS Logic Model: A Framework to Link Program Design With Assessment | Draft | 5/07/2024 |
| Generic Drugs | Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs | Draft | 4/29/2024 |
| Drugs | Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry | Draft | 4/24/2024 |
| Generic Drugs | Data Integrity for In Vivo Bioavailability and Bioequivalence Studies | Draft | 4/03/2024 |
| Generic Drugs | Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry | Final | 4/01/2024 |
| Electronic Submissions | Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry | Final | 4/01/2024 |
| Generic Drugs | Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples | Draft | 3/27/2024 |
| Real World Data / Real World Evidence (RWD/RWE) | Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products | Draft | 3/21/2024 |
| Generic Drugs | Controlled Correspondence Related to Generic Drug Development | Final | 3/18/2024 |
| ICH-Efficacy | E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports | Draft | 3/13/2024 |
| Labeling | Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products | Draft | 3/13/2024 |
| Clinical - Medical | Early Alzheimer’s Disease: Developing Drugs for Treatment | Draft | 3/12/2024 |
| ICH-Quality | Q14 Analytical Procedure Development | Final | 3/07/2024 |
| Clinical - Pharmacology | Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry | Final | 3/01/2024 |
| ICH-Quality | Q2(R2) Validation of Analytical Procedures | Final | 3/06/2024 |
| Administrative/Procedural | Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards | Draft | 2/29/2024 |
| Clinical - Medical | Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment | Final | 2/22/2024 |
| Procedural | Charging for Investigational Drugs Under an IND: Questions and Answers | Final | 2/14/2024 |
| Clinical - Medical | Use of Data Monitoring Committees in Clinical Trials | Draft | 2/13/2024 |
| Administrative/Procedural | Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act | Draft | 2/06/2024 |
| Administrative/Procedural | Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the FD&C Act | Final | 2/05/2024 |
| Clinical - Medical | Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products | Draft | 1/30/2024 |
| Generic Drugs | Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry | Final | 1/24/2024 |
| Generic Drugs | Requests for Reconsideration at the Division Level Under GDUFA | Draft | 1/10/2024 |
| ICH-Quality | Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin | Final | 1/10/2024 |
