The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format. In a revised ...

Add Yahoo as a preferred source to see more of our stories on Google. Two congressional lawmakers have asked a federal judge to appoint a special master to expedite the release of files related to the ...

JEFFREY Epstein’s long-time personal assistant – named 16,000 times in the files – labelled her former boss a “master ...

Representatives Ro Khanna (D-CA) and Thomas Massie (R-KY), the bipartisan co-sponsors of the Epstein Files Transparency Act, have asked a federal judge to appoint a Special Master to force the DOJ to ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

FDA has developed a new set of requirements for documenting the safety of dietary supplement ingredients. Manufacturers are able to market products with new ingredients without preapproval as long as ...

On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed ...

The Department of Justice (DOJ) Tuesday filed its response opposing the appointment of a "special master" to review documents seized from former President Donald Trump's Mar-a-Lago estate, saying ...