Attorney Scott Lassman petitions FDA to deny a Par Sterile Products sNDA seeking to modify dosing for Vasostrict based on patient genotype.
FDA names University of Michigan associate professor Kevin Fu to a one-year term as an expert-in-residence in cybersecurity.
FDA releases its latest batch of Warning Letters that include American Global Health Products and Entia Biosciences.
The Government Accountability Office recommends additional things that FDA and other federal agencies should be doing as part of their response to the...
FDA says a Boston Scientific recall of EMBLEM defibrillator electrodes due to potential fracturing is Class 1.
FDA clears an Inovytec 510(k) to market its Ventway Sparrow ventilators in the U.S.
FDA sets up an interim process to communicate issues identified following a review of records or other information requested prior to or in lieu of a ...
An FDA pilot program removes almost 30 illegal Web sites that were offering opioids for sale.