Federal Register notice: FDA seeks comments on a new information collection for De Novo Classification Process (Evaluation of Automatic Class 3 Design...
FDA warns Medical Center Pharmacy, Cleveland, TN about insanitary conditions and other violations in its compounding of sterile drugs.
Sen. Bernie Sanders and Rep. Peter DeFazio introduce a rule to require federal agencies to negotiate fair pricing agreements with companies producing ...
Four stakeholder groups praise FDA efforts in publishing the Biosimilar User Fee Agreement Statement of Work before the 10/1 anticipated agreement app...
FDA grants Bristol-Myers Squibb accelerated approval for Opdivo (nivolumab) for treating certain patients 12 years and older with mismatch repair defi...
FDA approves Celgenes Idhifa (enasidenib) for treating adult patients with relapsed or refractory acute myeloid leukemia who have a specific genetic m...
FDA publishes a guidance to help sponsors in clinical development of new antibacterial drugs.
Teva asks FDA to revise a draft guidance on pre-submission facility correspondence associated with priority ANDA submissions to remove information gat...