CDER says reorganization of the Office of New Drugs moved into Phase 2 11/4.
FDA releases an FDA-483 with seven observations issued following an inspection at Innoveix Pharmaceuticals.
Biopharma Reporter says that Pfizer CEO Albert Bourta is leading the effort to reform drug company rebates to payers that he says are slowing uptake o...
FDA launches a new Web page that encourages firms to inquire about the agencys current policies on digital health products.
Federal Register notice: FDA seeks industry organizations to participate in selecting nonvoting industry representative to serve on CBERs Allergenic P...
FDA warns Chinas Bingbing Pharmaceutical Co. about CGMP violations in its production of finished drugs.
A Kaiser Health News special report says FDA sometimes approves expensive innovative branded drugs despite manufacturing issues found in pre-market in...
A McKinsey white paper describes a holistic approach to transforming drug development that could accelerate the process by 500 days and reduce the cos...