FDA releases an FDA-483 with eight inspection observations from Repro-Med Systems, Inc.
FDA warns Chinas Changzhou Jintan Qianyao Pharmaceutical Raw Materials Factory about deviations from CGMP requirements for active pharmaceutical ingre...
Attorney Jennifer Thomas says the Supreme Court has declined to hear an appeal of a Park doctrine conviction by the DeCoster brothers.
FDA releases its latest batch of Warning Letters that includes Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory and Formulife, Inc.
Five stakeholders suggest ways in which FDA can improve a draft guidance on considerations for determining interchangeability of biologic products.
FDA grants Merck accelerated approval for Keytruda (pembrolizumab) for treating patients whose cancers have a specific genetic feature (biomarker).
FDA medical reviewers ask the Oncologic Drugs Advisory Committee to consider whether Hospiras Epogen/Procrit biosimilar, Epoetin Hospira, meets the re...
FDA says an Abbott-Thoratec recall of HeartMate II LVAS pocket system controllers is Class 1.