Federal Register notice: FDA sends to OMB an information collection extension for Product Jurisdiction: Assignment of Agency Component for Review of P...
FDA warns Mylan about significant deviations from CGMP requirements for active pharmaceutical ingredients at its Unit 8 in India.
FDA warns Indias Cadila Healthcare about CGMP violations in its manufacturing of finished pharmaceuticals.
Becton Dickinson files a PMA supplement for an expanded version of its BD Onclarity HPV Assay.
FDA approves a Hologic PMA for its 3DQuorum Imaging Technology for use with the companys Clarity HD high resolution imaging technology to reduce tomos...
Worried about device shortages that could occur from recent closures of facilities that use ethylene oxide to sterilize medical devices, an FDA adviso...
The International Medical Device Regulators Forum issues three final guidances relating to clinical evaluation, clinical evidence, and clinical invest...
FDA medical reviewers ask the Endocrinologic and Metabolic Diseases Advisory Committee to discuss efficacy and safety information on Amarins Vascepa.