Federal Register notice: FDA makes available a draft guidance entitled Nonbinding Feedback After Certain FDA Inspections of Device Establishments.
Federal Register notice: FDA makes available a draft guidance entitled Competitive Generic Therapies that is intended to help expedite the development...
Federal Register notice: FDA posts a final guidance entitled Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.
Federal Register notice: FDA makes available a final guidance entitled Evaluation of Devices Used with Regenerative Medicine Advanced Therapies that p...
Two stakeholders recommend improvements to an FDA draft guidance on development and labeling of oncology drug companion diagnostic devices.
An FDA safety alert warns consumers about establishments in several states that are offering young-donor plasma infusions to treat various conditions.
FDA approves a Novo Nordisk BLA for Esperoct (turoctocog alfa pegol) for treating adults and children with hemophilia A.
The Justice Department says the government has intervened in a whistleblower case alleging that Arriva Medical submitted false claims to Medicare for ...