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).
Psilera, Hesperos Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia
June 9th 2025The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
