Federal Register notice: FDA makes available a final guidance entitled Good ANDA Submission Practices.
The CDER Office of Prescription Drug Promotion says a Lilly social media post for Trulicity is false and misleading because it inadequately presents t...
Sens. Grassley and Warren urge FDA to quickly finalize its proposed rule on over-the-counter hearing aids.
Hanzo compliance product manager Will Walker says companies need interactive Web archives to be able to show FDA how consumers viewed promotional mate...
FDA would have many responsibilities under bipartisan legislation drafted to improve the nations pandemic and public health preparedness released by S...
Federal Register notice: FDA makes available a medical device final guidance on principles for using patient-reported outcome instruments.
Federal Register notice: FDA makes available a final guidance entitled Patient Engagement in the Design and Conduct of Medical Device Clinical Studies...
CDRH issues its annual report on the Accreditation Scheme for Conformity Assessment pilot program.