Medical device expert Marcelo Trevino analyzes for Med Device Online the results from the first 100 FDA inspections under the new Quality Management S...
FDA releases a guidance that is intended to assist industry in the submission of datasets from clinical studies that evaluate immunogenicity and its i...
Sen. Ron Johnson (R-WI) launches a new investigation into federal handling of Covid-19 vaccine safety issues, seeking records from HHS, FDA and CDC re...
A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient safety issue in gener...
FDA asks manufacturers of generic Accutane to update the drugs labeling.
FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accelerated approval for t...
FDA and the African Medicines Agency sign a Statement of Cooperation establishing a formal framework for collaboration between the U.S. regulator and ...
FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for treating neovascular ...
