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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?
eBook: Regulatory Sourcebook and Reference, March 2020
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).