Tag: Food & Drug Administration
FDA: Insulin Among Drugs Transitioned to Biological Products
New regulatory pathway for biologic drugs allows for approval of biosimilars, interchangeable versions
FDA Bans Electrical Shock Devices Used on the Mentally Disabled
Ban takes effect 30 days after publication in the Federal Register
Medtronic MiniMed 600 Series Insulin Pumps Recalled
Medtronic has received 26,421 complaints about malfunctions in the recalled insulin pumps
Fewer Than Half of Clinical Trials Comply With Reporting Laws
Compliance with Food and Drug Administration Amendments Act of 2007 low, not improving
Evolution of Approval, Regulation Processes for Drugs Explored
FDA drug review times down from 1983 to 2017, but time from clinical testing to approval did not change
FDA Approves Sale of Low-Nicotine Cigarettes
Nicotine content of the two newly approved cigarettes is less than 1 mg per cigarette
Hahn Confirmed as New FDA Chief
One major challenge facing Hahn is the teen vaping epidemic
FDA Sends Warning Letter About OTC Drugs to Dollar Tree
Letter outlines corrective actions company needs to take, including ensuring they do not import impure drugs
Dr. Stephen Hahn Nominated to Head FDA
Hahn is chief medical executive of The University of Texas MD Anderson Cancer Center in Houston
FDA Committee: Makena Should Be Removed From Market
Drug was approved by FDA in 2011 to reduce risk for preterm birth in at-risk women
