Two Mintz Levin attorneys say some significant changes are likely to occur in FDA in 2017 due to the incoming administration.
The Government Accountability Office says FDA needs to assess the contributions of its foreign offices to drug safety and better deal with the high nu...
FDA denies an AbbVie petition on requirements for demonstrating a biosimilars interchangeability with a reference product.
FDA publishes a draft guidance on communicating healthcare economic information on approved and investigational drugs to payors.
FDAs Center for Veterinary Medicine warns that the topical cancer medical fluorouracil cream intended for human use has caused death in household pets...
Drug distributor McKesson Corp. agrees to pay a record $150 million civil penalty for alleged violations of the Controlled Substances Act.
An ongoing CDRH customer service satisfaction survey score slips from 88% of respondents in 2015 reporting that they had received satisfactory respons...
FDAs Florida District Office warns Horizon Pharmaceuticals about CGMP violations for finished pharmaceuticals.