[ Price : $8.95]
FDA posts a guidance to support a CDRH-backed medical device single audit pilot program that will begin in January.[ Price : $8.95]
AdvaMed sharply criticizes a FDA proposal to make available masked and/or de-identified medical device sponsor data, saying the ag...[ Price : $8.95]
FDA clears a Reverse Medical 510(k) for its ReVerse Microcatheter product line for intracranial neurovascular use.[ Price : $8.95]
Researchers Thomas Moore and Curt Furberg say FDAs greater use of expedited review may be putting some patients at risk.[ Price : $8.95]
Charleston Laboratories stops a Phase 3 trial involving its anti-nausea pain drug CL-108 based on a recommendation from an indepen...[ Price : $8.95]
Attorney Peter Reichertz says manufacturers may be able to use FDAs PLAIR guidance to speed entry of approved products manufacture...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites King Systems Corp. for medical device QSR deviations.[ Price : $8.95]
FDA clears an Ethicon Endo-Surgery 510(k) for the Harmonic Ace+ 7 Shears with Advanced Hemostasis, intended for use is sealing ves...