Attorney T. Daniel Logan analyzes the impact on FDA of HHS regulations on good guidance practices.
Three former FDA commissioners praise the agencys work to date in Covid-19 vaccine development in a politically charged environment.
CyberMDX says that GE imaging systems have a cyber vulnerability that could put system operation and patient data at risk.
Public Citizen says the HHS Inspector General should probe FDA collaboration with Biogen to salvage the Alzheimers drug aducanumab.
Stakeholders suggest revisions to an FDA draft guidance on pharmacokinetics in patients with impaired renal function.
FDA expands its partnership with Palantir Technologies through a new $44.4 million three-year contract.
Federal Register notice: FDA releases a final guidance entitled Best Practices in Developing Proprietary Names for Human Prescription Drug Products.
Federal Register notice: FDA makes available a draft guidance entitled Best Practices in Developing Proprietary Names for Human Nonprescription Drug P...