Sens. Shaheen and Collins call on FDA to modify the regulatory pathway for deceased donor islet cell transplantation for some Type 1 diabetes patients...
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...
Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makarys initiatives following his resignation.
A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...
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.
