[ Price : $8.95]
Federal Register Notice: FDA terminates the Medical Device ISO Voluntary Audit Report Pilot Program.[ Price : $8.95]
Former psychiatry professor Daniel Kripke says FDA should take numerous actions to restrict use of so-called hypnotic drugs becaus...[ Price : $8.95]
FDA says it needs targeted user fees for reviewing medical device submissions containing patient-reported outcome data because the...[ Price : $8.95]
FDA lifts a clinical hold against all Advaxis INDs for three product candidates axalimogene filolisbac (formerly ADXS-HPV), ADXS-...[ Price : $8.95]
FDA approves a Merck supplemental BLA for Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant) to included the products...[ Price : $8.95]
Cardica says it has submitted FDA-requested animal study data to support its 510(k) seeking an expanded indication for its MicroCu...[ Price : $8.95]
The Association for Molecular Pathology says an FDA report justifying agency oversight of laboratory-developed tests ignored facts...[ Price : $8.95]
FDA drops the REMS requirement for Type 2 diabetes drugs containing rosiglitazone.