Not the result of new legislation or regulations. Creates a super-office to do the work they’re already doing (or as with Amarin – the work they should be doing but are not) but with perhaps a bit more coordination. Looks like your typical government reshuffling of duties and responsibilities to claim they’re working better, communicating better, making things safer and ensuring more transparency. Existing workers are realigned. The union was notified. More or less the government equivalent of putting lipstick on a pig. If they are under the gun from Congress for past inefficiencies – the reorg may buy them some more time to get their act together before congress can hold their feet to the flame. http://www.bna.com/fdas-drug-center-n17179872570/ Speaking at the Generic Pharmaceutical Association's (GPhA) annual conference, Hamburg said the new office would not impose any new quality requirements but rather enforce existing quality standards. http://blog.pharmexec.com/2014/10/17/cder-super-office-to-promote-drug-quality/ A main change, which will go live Jan. 5, 2016, is to shift to OPQ the functions performed by CDER’s Office of Pharmaceutical Science (OPS), which oversees the chemistry, manufacturing and controls submissions for drugs and biologics and conducts research on drug formulation and manufacturing issues. The new office also will house surveillance functions related to preapproval and surveillance inspections now carried out by CDER’s Office of Compliance, with an eye to achieving uniform quality oversight for new drugs, generics and over-the-counter products. …..Woodcock said in her message. Manufacturers will gain feedback on quality deficiencies earlier in the review cycle, and FDA will be able to provide a more uniform quality program across domestic and foreign manufacturing sites, and across all drug product areas. The result will be “consistent approaches, a transparent process, and clear standards to which the regulated industry must conform,” she commented. http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/12/office-of-generic-drugs-super-office-becomes-a-reality-new-office-of-generic-drug-policy-will-handle.html As a part of the Office of Pharmaceutical Quality (OPQ) proposal, OPQ is proposed to house the product quality-related groups, including CMC and Microbiology review functions, which had previously been in OGD to ensure efficiency and consistency of standards and actions across the Center and drug product lifecycle. As OGD is now a super office, approximately 200 CMC and Microbiology reviewers in OGD will remain in the Office of Pharmaceutical Science, and then move into the new OPQ when it is established…..
The OGD reorganization is a part of our ongoing efforts to ensure that the generic drug industry is held to standards of high quality – and our ongoing efforts to expedite the availability of safe, effective, and high quality generic drugs to patients. It also underscores our commitment to maintaining the public’s confidence in an Agency that continues to meet the ever-changing needs of the American public health. http://www.gphaonline.org/media/cms/Janet_Woodcock.pdf
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