[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on the MedWatch reporting program to the Office of Manag...[ Price : $8.95]
Federal Register Notice: FDA plans a public meeting 12/16 to discuss the recommendations for a user fee program for biosimilar bio...[ Price : $8.95]
AdvaMed, PhRMA, and BIO voice support for FDAs draft guidance promoting a risk-based approach to clinical investigation monitoring...[ Price : $8.95]
HHS secretary Kathleen Sebelius orders FDA to reverse its internal decision and deny a Teva sNDA to allow Plan B One-Step to be ma...[ Price : $8.95]
Washington commentator Robert F. Steeves sees HHS commentator Kathleen Sebelius over-ruling of FDAs Plan B decision as a denial of...[ Price : $8.95]
CDRH Office of Compliance director Steve Silverman outlines his office's next steps to properly align its regulatory approach towa...[ Price : $8.95]
CDER Office of Manufacturing & Product Quality associate director Rick Friedman tells FDLI that the agency is concerned about labo...[ Price : $8.95]
FDA is expected to rule this week on whether Tevas Plan B emergency contraceptive can be sold openly on store shelves.