FDA Update: March 2026

Below is a list of updates for March 2026.

• Guidance: Recommendations on Scale-Up and Postapproval Changes (Federal Register)
• Guidance: E2D(R1) Postapproval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports; International Council for Harmonisation (Federal Register)
  • E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (Final)
• Guidance: M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation (Federal Register)
  • M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines (Final)
• Guidance: New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers (Federal Register)
  • New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers (Draft)
• FDA Warns 30 Telehealth Companies Against Illegal Marketing of Compounded GLP-1s (Press Release)
• Artri Ajo Rev and Artri Ajo King may be harmful due to hidden drug ingredients (CDER Public Notification)
• Meeting Minutes: FDA-Industry MDUFA VI Reauthorization Meeting, February 11, 2026 (CDRH Update)
• February 25, 2026 Approval Letter – PAPZIMEOS (CBER News)
• BK251232- PRF-Matrix System (CBER News)
• Rule: Revising the National Drug Code Format and Drug Label Barcode Requirements (Federal Register)
• FDA to Address Unused Opioids in American Homes (Press Release)
• FDA Grants Third Approval Under the National Priority Voucher Program (Press Release)
• Notice: Developing Specifications for In-Home Disposal Systems for Opioid Analgesics Dispensed in an Outpatient Setting (Federal Register)
• FDA Holds Meeting with States on Importation of Lower Cost Drugs (Press Release)
• Guidance: Responding to Food and Drug Administration Form 483 Observations at the Conclusion of a Drug Current Good Manufacturing Practice Inspection (Federal Register)
  • Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection (Draft Guidance)
• Guidance: New and Revised Draft Q and As on Biosimilar Development and the Biologics Price Competition and Innovation Act (Federal Register)
  • New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry
  • Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry (Final Guidance)
• FDA Takes Further Steps to Streamline Biosimilar Development and Make Medicines More Affordable (Press Release)
• FDA Approves First Treatment for Patients with Cerebral Folate Transport Deficiency (Press Release)
• FDA Adverse Event Monitoring System (AEMS)(LinkedIn Update)
• FDA Launches New Adverse Event Look-Up Tool (Press Release)
• Guidance: Medical Devices with Indications Associated with Weight Loss—Premarket Considerations (Federal Register)
  • Medical Devices with Indications Associated with Weight Loss – Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff (Final Guidance)
• Proposed Rule: General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; Withdrawal (Federal Register)
• Advancing Real-World Evidence Program (Press Release)
• Office of Translational Sciences 2025 Annual Report
• Guidance: Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in Abbreviated New Drug Applications (Federal Register)
  • Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (Final Guidance)
• Proposed Rule: Effective Date of Requirement for Premarket Approval Applications for Blood Irradiators Intended to Prevent Metastasis (Federal Register)
• Proposed Rule: Medical Devices: Radiology Devices; Classification of Blood Irradiators (Federal Register)
• FDA Releases Draft Guidance on Alternatives to Animal Testing in Drug Development (Press Release)
• Guidance: General Considerations for the Use of New Approach Methodologies in Drug Development (Federal Register)
  • General Considerations for the Use of New Approach Methodologies in Drug Development: Draft Guidance for Industry (Draft Guidance)
• FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide (Press Release)
• FDA Schedules Public Meeting on the Commissioner’s National Priority Voucher Pilot Program (Press Release)
• FDA Approves Drug to Treat Neurologic Manifestations of Hunter Syndrome (Press Release)
• FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I (Press Release)
• Proposed Rule: Microbiology Devices: Reclassification of Mycobacterium tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests (Federal Register)
• Notice: Guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle (Federal Register)
  • Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Guidance for Industry, Food and Drug Administration Staff, and Other Interested Parties (Final Guidance)
• Notice: Request for Information: Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products (Federal Register)
• FDA Approves First Gene Therapy for Severe Leukocyte Adhesion Deficiency Type I (Press Release)