FDA Invites Public Comments on Drug Compounding

The United States Food and Drug Administration (“FDA”) has been working towards implementing the Drug Quality and Security Act (“the act”) since the laws inception in 2013. They have issued multiple notices for input on a multitude of specific issues under the act, however, they have not invited general comment on the act.

On March 6, 2015, the FDA issued a general invitation to the public for comment on implementation of the act. The invitation for comment is related to regulations on human drug product compounding under section 503A and 503B of the act. However, it is designed to accept comments, recommendations, and information about the entire act, especially for issues that have not been addressed in other public dockets.

The comment period is being held open indefinitely. The invitation in the Federal Register may be found at the following link: https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-05376.pdf

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Improvements in FDA Approval Timelines

According to a third party report by Pricewaterhouse Coopers (PwC), the Food and Drug Administration (FDA) has decreased the standard review time for new drugs, biologics, and devices. The report indicates the standard review time in 2009 was 14 months, but in 2012, it had decreased to 7 months.

Although low-priority new drug applications continue to require multiple review periods, high-priority applications were approved in the first review process at a rate of 81% in 2012. That represents a substantial increase in approval rates during the first review process. Similarly, as part of the Food and Drug Administration Safety and Innovation Act of 2012, the breakthrough therapy pathway has proven successful. Since its inception, it has received 260 applications, designating 74, and approving 17.

A full copy of the report regarding the FDA can be obtained at the following link: http://www.pwc.com/us/en/health-industries/health-research-institute/hri-pharma-life-sciences-fda.jhtml

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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

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