FDA Center for Drug Evaluation and Research Starts New Office for Monitoring Drug Quality

On January 12, 2015, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) started a new office for monitoring drug quality. The Office of Pharmaceutical Quality (OPQ) will focus on drug application reviews, post-approval improvements, and monitoring pharmaceutical manufacturing.

This new office will primarily focus on ensuring that patients receive safe, quality products. In doing so, the OPQ will evaluate all aspects of drug quality to ensure consumer safety. Having established the new office, the FDA hopes to streamline quality control and monitoring processes for the benefit of the industry and consumer alike.

More information and answers to some specific questions may be found at the FDA website by following the link:

http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm429869.htm

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FDA Proposed Guidance for 2015

The U.S. Food and Drug Administration (FDA) released a list of all the planned guidance for issuance in 2015. This list includes new guidance for items within Biopharmaceutics, Drug Safety, Pharmaceutical Quality, and other categories.

The full list of proposed guidance for 2015 by the FDA may be found at the following link:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417290.pdf

© 2015 Houghton Vandenack Williams Whitted Weaver Parsonage LLC

For more information, Contact Us