Pharmaceutical Technology - March 2020

Pharmaceutical Technology - Regulatory Sourcebook

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4 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m Regulatory Update I n a February 2020 report (1), FDA's Office of Pharmaceutical Qual- ity (OPQ) noted that, "Quite simply, the quality of our drug sup- ply is better than ever before." OPQ, which was launched in 2015 to oversee quality standards for all innovator and generic drugs marketed in the United States, noted a number of achievements in 2019, including 357 inspections for application approval and nearly 200 quality assessments of applications expedited by OPQ to avert potential drug shortages for patients. In noting other progress, FDA reported that the sixth continuous manufacturing application—one to meet a medical need for cystic fibrosis patients—was approved in three months, compared with a typical approval time of nearly 10 months. Public perceptions about drug quality can be off target from reality. A 2019 survey conducted by FDA and WebMD found that nearly one-quarter of physicians surveyed believed an advertise- ment for a drug was an indicator of quality. However, nearly half of the physicians responding to that survey said drugs manufac- tured abroad were of lower quality than those manufactured in the United States. That assessment is troubling, in light of the number of APIs that are manufactured offshore and disruptions to quality oversight efforts. Regulatory enforcement, as normal Through early March 2020, FDA reported eight drug recalls, includ- ing four related to nitrosodimethylamine impurities (2), an ongoing concern traced to quality problems with the manufacture and testing of APIs manufactured overseas. On the compliance front, FDA's Center for Drug Evaluation and Research—through mid-March 2020—issued 12 warning letters to ALEXLMX - STOCK.ADOBE.COM A "New Normal" for Quality? Rita Peters With FDA offshore inspections on hold, will the US drug supply maintain its quality standards?

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