Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development and approval. Below are the relevant links to updates provided for both COVID-19 related and non-COVID-19 related programs in October 2021.
New FDA Guidance Documents:
Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide: Guidance for Industry (published 29-Oct-2021) Download FDA Guidance
New Draft Guidance Documents:
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals: Draft Guidance for Industry (published 06-Oct-2021)
Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry: Draft Guidance for Industry (published 29-Oct-2021)