FDA says the pandemic affected its ability to complete regulatory actions for inspected facilities within six months of the inspection closing during ...
Former FDA deputy commissioner for medical and scientific affairs Anand Shah joins Big Healths board of directors.
Law firm Hogan Lovells hires former FDA investigator Chris Middendorf as the firms regulatory affairs director.
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...