FDA Approvals - FDA lifts warnings against 2 Medtronic plants, clearing way for
FDA lifts warnings against 2 Medtronic plants, clearing way for new product approvals
WASHINGTON - Medtronic Inc., the world's largest medical device company, said Wednesday it has resolved two warning letters from the Food and Drug Administration over lax oversight at two manufacturing plants, clearing the way for new product approvals.
FDA Grants 510(k) Clearance To Life Technologies Stem Cell Growth Medium
Life Technologies Corporation (Nasdaq: LIFE) announced it has received FDA 510(k) clearance for StemPro MSC SFM a first for this next-generation stem cell culture medium that is now cleared as a medical device and satisfies a crucial requirement for researchers involved in clinical trials in the United States. The StemPro MSC SFM is a liquid medium intended for human ex vivo (outside the body ...
FDA And NCI Officials To Address Tobacco Law, Research At AACR Briefing
In 2009, a historic new law granted the U.S. Food and Drug Administration (FDA) authority to regulate the manufacturing, marketing and sale of tobacco products. The FDA will give an update on the implementation of the Family Smoking Prevention and Tobacco Control Act at a congressional briefing hosted by the American Association for Cancer Research on Wednesday, March 16. Lawrence Deyton, M.D ...