Federal Register notice: FDA makes available guidance documents related to the coronavirus disease 2019 (Covid-19) public health emergency.
FDA grants Rutgers Clinical Genomics Laboratory an emergency use authorization for the first diagnostic test with the option of using home-collected s...
FDA cites RC Outsourcing (Lowellville, OH) for GMP issues after the drug outsourcing facility was inspected in February.
Senators Elizabeth Warren (D-MA) and Patty Murray (D-WA) ask FDA how it is tracking the use, safety, and effectiveness of scores of products on the ma...
Federal Register notice: FDA makes available a final guidance on developing drugs for cytomegalovirus in transplantation.
A German researcher says that over 1,000 clinical trials having been stopped due to restrictions brought on by the Covid-19 virus.
FDA posts summarized performance data for 12 antibody (serology) tests that have been granted emergency use authorizations for detecting the bodys imm...