Five stakeholders express appreciation for a revised FDA draft guidance on pharmacogenomic data submissions and suggest changes to it.
Thirteen state attorneys general call on FDA to develop a plan for disposal of opioid drugs that includes at-home, single-use disposal products.
Senator Marco Rubio questions FDAs decision to temporarily permit the importation of unapproved cisplatin, an important chemotherapy drug in short sup...
FDA approves Boehringer Ingelheims Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as treatments for improving bloo...
Twenty-five bipartisan House representatives urge FDA to create patient-centered policies on compounded hormones that maintain patients access to care...
Federal Register notice: FDA makes available a final guidance entitled Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Progr...
Federal Register notice: FDA permanently debars Daylen Diaz from providing services in any capacity to a person that has an approved or pending drug p...
The Physicians Committee for Responsible Medicine asks FDA to require a notice on all glucagon-like peptide-1 receptor agonists that a plant-based die...
