Federal Register notice: FDA announces a 10/7 meeting of its Medical Devices Advisory Committees Circulatory System Devices Panel, which will discuss ...
Bayshore Pharmaceuticals recall two lots of metformin hydrochloride extended-release tablets due to the detection of N-nitrosodimethylamine levels abo...
Federal Register notice: FDA corrects a notice that appeared in the 7/7 Federal Register that discussed version 1.7 of the Clinical Data Interchange S...
CBER director Peter Marks says he would resign if the Trump Administration interfered in an approval decision to speed up access to a premature Covid-...
Federal Register notice: FDA sends to OMB an information collection extension on Focus Groups as Used by the Food and Drug Administration (All FDA-Reg...
Federal Register notice: FDA seeks comments on a revised information collection on Registration of Human Drug Compounding Outsourcing Facilities and A...
Federal Register notice: FDA sends to OMB an information collection on medical device corrections and removals reporting.
A new Trump Administration initiative exempts laboratory-developed tests, including those for Covid-19, from the need to get FDA premarket review.