Tag: CMC

CDER SBIA Regulatory Education for Industry (REdI) Annual Conference 2020 Recordings

Recordings and slides are available for the 2020 REdI Annual Conference. Day One  Real-world Evidence for Drugs, Biologics, and Devices So, Your NDA Was Approved – Now What?! Post-approval Responsibilities Obligations Restructure of the Office of New Drugs (OND) Overview of Postmarketing Drug Safety Reporting Requirements Enhanced Drug Distribution Security – DSCSA Implementation Updates Drug […]

Posted FDA Guidance Documents

10/24/2019 – Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry This guidance provides information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(o)(3)), which authorizes FDA to require certain postmarketing studies and clinical trials […]

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