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July 17, 2015
A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.
FDA releases a report that analyses why some diseases are lacking treatment options.
July 16, 2015
The agency has released guidance on bioequivalence studies for asenapine, prasugrel, sitagliptin, and zonisamide.
July 14, 2015
FDA released news of the ban of Emcure’s Hinjewadi manufacturing plant after it determined the plant did not meet basic quality standards.
The agency requires early notification of potential drug shortages.
July 13, 2015
The European Medicines Agency reviews the safety of human papillomavirus vaccines.
July 07, 2015
FDA orders unapproved prescription ear drop products with active ingredients removed from the market.
The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.
July 02, 2015
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
July 01, 2015
US Court orders New Jersey drug manufacturer and its president to stop distribution of unapproved and misbranded drugs.