Drugs

OPQ Site Visit Locations Sought

The CDER Office of Pharmaceutical Quality (OPQ) is asking interested drug companies to submit proposals to serve as a location for the OPQ staff experiential learning site visit program. A Federal Register notice says that a critical part of the Center’s commitment to make safe and effective high-quality drugs available to the American public is gaining an understanding of all aspects of drug development and a drug’s commercial life-cycle, including the variety of drug manufacturing operations. The site visit program offers OPQ staff experiential and first-hand learning opportunities that will provide them with a better understanding of the pharmaceutical industry and its operations, as well as of the challenges that affect a drug’s development program and commercial life-cycle.

OPQ participants will observe operations of commercial manufacturing, pilot plants, and testing over a 1-2-day period. The notice says that companies engaging in the development and manufacturing of both drug substances and drug products are encouraged to respond. The notice says that areas of interest to staff include drug products and active pharmaceutical ingredients; design, development, manufacturing, and controls; and emerging technologies.

Proposals are to be submitted within 60 days.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome