FDA issues an early alert about a Medline recall for specific lots of Medline Kits containing Medtronic DLP Left Heart Vent Catheters based on an earl...
FDA warns Indias Somerset Therapeutics about CGMP and Field Alert Reporting violations in its production of finished drugs.
A Center for Innovation in Regulatory Science briefing paper stresses Chinas faster drug approvals and the need for sponsors to make coordinated submi...
FDA releases 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it unveiled a major pus...
FDA posts a draft guidance entitled Erosive Esophagitis: Developing Drugs for Treatment that outlines recommendations for developing such products.
FDA releases the form FDA-483 with four observations from an inspection at the Lupin drug manufacturing facility in Madhya Pradesh, India.
Becton Dickinson expands its Class 1 recall of its Alaris Pump Module model 8100 to include 15 additional infusion sets, citing potential performance ...
FDAs ongoing crack down on drug direct-to-consumer promotional activities results in three just-released Warning Letters to Eli Lilly and one to Novo ...
