A ‘New Normal’ for Quality?
With some FDA inspections on hold, will the US drug supply maintain its quality standards?
In February 2020, a report from FDA’s Office of Pharmaceutical Quality (OPQ) noted that, “Quite simply, the quality of our drug supply is better than ever before.” With some FDA inspections on hold, will the US drug supply maintain its quality standards? Plus, which new drug applications must now be filed as biologic license application?
Read this article in Pharmaceutical Technology’s March 2020 Regulatory Sourcebook.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook and Reference, March 2020
March 2020
Pages: 4–5
Citation
When referring to this article, please cite it as R. Peters, “A “New Normal” for Quality?" Pharmaceutical Technology Regulatory Sourcebook and Reference eBook (March 2020).
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
