A former Becton Dickinson safety official petitions FDA to refer the company to the U.S. Justice Department for allegedly violating the False Claims A...
FDA warns Arbor Centers for EyeCare about objectionable conditions in its conduct of two clinical investigations.
Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy Regarding Investigational New Drug Requirements for Use of F...
Lexicon asks that its NDA for sotagliflozin be approved to treat Type 1 diabetes or that a hearing be held to resolve issues of fact about the NDA.
Five stakeholders recommend changes to an FDA proposed rule on nonprescription drug products with an additional condition for nonprescription use.
Roche withdraws a Tecentriq (atezolizumab) accelerated approval indication for treating certain adults with locally advanced or metastatic urothelial ...
Federal Register notice: FDA withdraws the approval of Mylans Sulfamylon (mafenide acetate, USP) powder for 5% topical solution after the company requ...
Researchers document the Medicare savings associated with skinny label biosimilars.
