In July of this year, we reported that FDA Announces Strategic Plan to Eliminate Orphan Designation Request Backlog. On September 12, 2017, Commissioner Gottlieb stated that “Reviews of all orphan drug designation requests older than 120 days were completed on August 28th.” In the same report, entitled “FDA is Advancing the Goals of the Orphan…
DetailsThe Albert and Mary Lasker Foundation reports that “The 2017 Lasker-DeBakey Clinical Medical Research Award honors two scientists whose technological advances enabled the development of human papillomavirus (HPV) vaccines, which prevent cervical cancer and other tumors. Douglas R. Lowy and John T. Schiller (both from the National Cancer Institute) took a bold but calculated approach toward a major public-health problem whose…
DetailsMostaghim et al (BMJ 2017;358:j3837) recently published a study in the British Medical Journal that concludes that “Expedited development and regulatory review pathways can accelerate the availability of new drugs, but drugs approved through these pathways are associated with increased safety related label changes after approval, particularly for the types of changes representing the highest risk…
Details“FDARA reauthorizes the Prescription Drug User Fee Act (PDUFA) for the fifth time, the Medical Device User Fee Amendments (MDUFA) for the third time, and both the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA) for the first time – allowing FDA to continue to collect medical product user fees…
DetailsAlthough not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still become law. Assuming passage, OTC User Fees and electronic submissions will be required and sponsors will have the opportunity to engage in pre-submission meetings with FDA before requesting changes to OTC monographs. The process for effecting such…
DetailsAccording to Rare Disease Report, “It is only August but the U.S. Food and Drug Administration (FDA) is on track to set a record for orphan drugs approved this year. At last count, 42 orphan drugs have been approved between January 1, 2017 and August 9, 2017.” Meanwhile, RAPS Regulatory Focus reports that “A little…
DetailsUSA Today reported on August 15 that “Drugmakers ‘game the system and game the rules’ through a patient safety program that allows them to keep generic drug companies from getting enough doses of their branded drug, said Gottlieb. Generic drugmakers need up to 5,000 doses to do the studies needed to prove their products are truly equivalent, he…
DetailsTheresa M. Mullin, Ph.D. of FDA reports “I am pleased to have been in China recently, when the China Food and Drug Administration (CFDA) submitted its membership application to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (also known as the International Council for Harmonisation or ICH).” Click here for the…
DetailsOn August 15, 2017, FDA updated its page entitled Product-Specific Guidances for Generic Drug Development. In October 2016 we reported that “FDA Adds 67 New/Revised Product Specific Bioequivalence Guidances.” This latest addition is noteworthy because it includes finalized bioequivalence guidances, which the Agency has not done since September 2015. Click here to see the additions…
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FDA User Fees for Reliance on the FDA OTC Monographs? Although not included in FDARA, there is a reasonable possibility the proposed Over-the-Counter Monograph User Fee Program (OMUFA) will still become law. Assuming passage, Over-the-Counter (OTC) User Fees and electronic submissions will be required and sponsors will have the opportunity to engage in pre-submission meetings…
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