FDA issues a guidance on its implementation of the 510(k) third party review program.
FDA releases the FDA-483 with seven inspection observations from the Maitland Labs of Central Florida outsourcing facility.
Federal Register notice: CDER has announced that it will begin supporting new e-submission standards for Animal Rule submissions effective 3/15.
Federal Register notice: FDA makes available a draft guidance entitled Providing Regulatory Submissions in Alternate Electronic Format.
Four stakeholders raise varying concerns with the FDA/HHS proposal to allow some state drug importation programs.
FDA again rejects Intarcia Therapeutics ITCA 650 exenatide implant intended to treat Type 2 diabetes.
FDA posts two documents on the potential shortage of personal protective equipment for healthcare organizations and staff during the Covid-19 outbreak...
FDA grants accelerated approval for Bristol-Myers Squibbs Opdivo and Yervoy in hepatocellular carcinoma patients who were previously treated with Baye...