Regulatory Developments

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 ...

Table of Contents Regulatory Developments January 2023 Learn about recent draft guidances from December 2022 to January 13, 2023. GUIDANCES Type Title Status Date Labeling Dosage and Administration Section of Labeling for Human Prescription ...

Table of Contents Regulatory Developments January 2021 Learn about recent draft guidances, such as updates to Federal Drug Administration drug safety forms, updates regarding product labeling, an assessment on COVID-19-related symptoms. GUIDANCES ...

Table of Contents Regulatory Developments December 2021 Learn about recent draft guidances as of November 2021. GUIDANCES Type Title Status Date Premarket, 510(k) Enforcement Policy for Viral Transport Media During the Coronavirus ...

Table of Contents Regulatory Developments October/November 2021 Learn about recent draft guidances as of September 2021. GUIDANCES Type Title Status Date Premarket, Chemistry, Manufacturing, and Controls (CMC), Current Good Manufacturing ...