Chinese citizen Gao Mei Fang pleads guilty to smuggling and mail fraud charges arising from a scheme to sell mislabeled dietary supplements.
An Arizona federal jury awards a plaintiff $3.6 million in a bellwether case involving C.R. Bards inferior vena cava filter.
FDA grants Proteostasis Therapeutics a fast track designation for its triple combination product for treating cystic fibrosis.
Federal Register Final Rule: FDA amends the animal drug regulations to reflect recent application-related actions for NADAs and ANADAs.
FDA accepts for priority review a Pfizer NDA for dacomitinib, a pan-human epidermal growth factor receptor tyrosine kinase inhibitor, for first-line t...
FDA clears an Aesku Group 510(k) for its Aeskuslides nDNA (Crithidia luciliae) assay and its use on the companys new Helios Automated IFA System.
Federal Register Final Rule; technical amendment: FDA amends certain medical device regulations to correct editorial issues, such as typographical err...
Endo agrees to extend for 180 days a stay in its suit against FDA over agency policy in compounding using bulk drug substances.