[ Price : $8.95]
During the current budget impasse on Capitol Hill and partial government shutdown, FDA says it cannot accept medical product submi...[ Price : $8.95]
FDA issues a guidance on developing and reviewing IDE applications for early feasibility studies of significant risk devices.[ Price : $8.95]
Federal Register Notice: FDA extends the comment period on a 6/4 Federal Register notice on the proposed availability of de-identi...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on recordkeeping requirements for institutional review boards.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information on studies about biological product communicat...[ Price : $8.95]
Former FDA district director John Scharmann says CDRHs plan to pilot pay-for third-party inspections in January is likely to be as...[ Price : $8.95]
Vertex Pharmaceuticals files a supplemental NDA for Kalydeco (ivacaftor) monotherapy for people with cystic fibrosis aged six and ...[ Price : $8.95]
CDER releases a draft guidance on ANDA Submissions ― Refuse-to-Receive Standards that describes what should be included in a...