Tag: Food & Drug Administration
FDA Receives an ‘F’ in Tobacco Prevention Report Card
American Lung Association releases State of Tobacco Control 2019 report
FDA Approves First Generic Version of Epilepsy Drug Sabril
Generic equivalents held to same vigorous manufacturing standards as brand-name drugs
FDA Down to 5 Weeks of Funding to Review New Drug Applications
Agency cannot accept new fees or applications until the shutdown is over
FDA to Resume Inspections of Riskier Foods
Agency is bringing back about 150 unpaid employees for the inspections of riskier foods
U.S. Food Supply May Be at Risk Due to Government Shutdown
Number of routine food inspections performed by the FDA dropped sharply
FDA Approves Drugs for Treatment of Two Rare Blood Diseases
Elzonris approved to treat BPDCN; Ultomiris approved for paroxysmal nocturnal hemoglobinuria
FDA Announces Safety Monitoring Measures for the Essure Device
Measures include having women in the postmarket surveillance study followed for five years, not three
FDA Warns Companies on Unsafe, Unapproved Stem Cell Treatments
Patients contracting deadly infections at clinics offering the unapproved treatments
FDA Approves Firdapse for Rare Autoimmune Disorder
First agency-sanctioned treatment for adults with Lambert-Eaton myasthenic syndrome
FDA Approves Treatment for AML Patients With Gene Mutation
Expanded approval also granted to mutation assay used to detect FLT3 mutation in AML patients
