[ Price : $8.95]
FDA tells an industry meeting it is still actively considering a Genentech petition that it regulate all laboratory-developed diag...[ Price : $8.95]
FDA approves a Phase 3 OncoVEX trial in treating squamous cell head and neck cancer.[ Price : $8.95]
FDA releases drug safety labeling changes approved in August, including three new Boxed Warnings.[ Price : $8.95]
CBER associate director for review management Robert Yetter discusses pit falls sponsors can avoid as part of their drug/biologic ...[ Price : $8.95]
A 47-page petition to FDA from 17 parties seeks reconsideration of the agencys controversial 8/4 final rule on dental mercury amal...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Bayer, EFT Biotech, Evenflo, Hill Dermaceuticals, and Synflex America.[ Price : $8.95]
Consulting editor John Scharmann reviews commissioner Margaret Hamburgs new Warning Letter close-out policy and finds it a good id...[ Price : $8.95]
FDA says an inspection at Bayer Schering Pharmas Bergkamen, Germany, API facility found significant cGMP deviations.