FDA Making Changes to Drug and Manufacturing Oversight

FDA Making Changes to Drug and Manufacturing Oversight

December 26th, 2014 // 8:23 pm @

FDA Commissioner Margaret Hamburg, MD, is seeking new ways for the agency to deal with its complex regulatory roles, especially as it pertains to drugs.

In 2013, Hamburg came up with a new agency wide organization to make key recommendations to improve how FDA centers deal with its audit employees. The result of that effort is the new Program Alignment Group Plan that will integrate the centers and field oversight operations.

CDER also is enacting a large reorganization that is made to improve old quality programs and to better ensure drug quality. The director of CDER, Janet Woodcock, is setting up a new Office of Pharmaceutical Quality or OPQ. The idea is to provide a single voice for drug quality that will coordinate research, review and audit duties as they pertain to quality.

The inspection functions done by the Office of Regulatory Affairs are being revised. For drugs, one of the big efforts will be to enact a pharmaceutical inspectorate with specialized expets that will both inspect and evaluate manufacturing processes for drugs. CDER staff is going to work in certain CGMP audits more and will give additional input into the scheduling of inspections, as well as enforcement.

Also up for overhaul is the manufacture registration and inventory databases. This will harmonize all center and data systems at ORA. This will use facility IDs that are most common, codes for products and modern software platforms that allow everyone to access data of facilities, AERs, risk info and field inventory.

The reorganization of CDER will go live in early 2016, and will shift most functions of the Office of Pharmaceutical Science over to OPQ. OPQ is then going to evaluate CMC submissions for pharmaceuticals, biotechnology and generic drugs.




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