|
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 |
