Is There a “New Normal” for Drug 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 BioPharm International’s March 2020 Regulatory Sourcebook.
Article Details
BioPharm International
eBook: Regulatory Sourcebook and Reference, March 2020
March 2020
Pages: 4–5
Citation
When referring to this article, please cite it as R. Peters, “Is There a “New Normal” for Drug Quality?" BioPharm International Regulatory Sourcebook and Reference eBook (March 2020).
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
