Regulatory Developments

Learn about recent draft guidances as of April 1, 2024 to July 9, 2024.  Regulatory Developments July 2024 GUIDANCES Type Title Status Date Combination Products Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, ...

Learn about recent draft guidances from the past 30 days. GUIDANCES Type Title Status Date Administrative/Procedural Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When ...

Table of Contents Regulatory Developments June 2023 GUIDANCES Type Title Status Date Premarket, 510(k), Labeling, Ophthalmic Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) ...

Table of Contents Regulatory Developments June 2023 Learn about recent draft guidances from May 1 to May 18, 2023. GUIDANCES Type Title Status Date Center for Drug Evaluation and Research Center for Biologics Evaluation and Research ...

Table of Contents Regulatory Developments March 2023 By Gail McGrew, Science Writer FDA updated guidance on Statistical Approaches to Establishing Bioequivalence, published during December 2022, updates the requirements for submitting bioavailability ...