Lundbeck's asedebart, which blocks ACTH signaling at its source, has won FDA orphan status for endogenous Cushingsyndrome.
|Articles|March 15, 2020
- BioPharm International-03-15-2020
- Volume 2020 eBook
- Issue 2
Is There a “New Normal” for Drug Quality?
Author(s)Rita C. Peters
With some FDA inspections on hold, will the US drug supply maintain its quality standards?
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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?
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).
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Regulatory and Standard Setting Organizationsover 6 years ago
Monograph Development: Why and When to Participate (eBook)over 6 years ago
A Practical Approach to Pharmacopoeia Compliance (eBook)over 6 years ago
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