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CDRH UDI regulatory policy analyst Christina Savasaar says two key changes were made between draft and final guidances on UDI dire...[ Price : $8.95]
Advocacy group Public Citizen petitions FDA to add cesium chloride to its 503A Category 2 list of bulk drug substances identified ...[ Price : $8.95]
Two FDAers say the agency has issued a Predictive Toxicology Roadmap and will hold a public workshop to help foster opportunities ...[ Price : $8.95]
FDA grants full approval for Genentechs Avastin (bevacizumab) for treating adults with glioblastoma that progressed following prio...[ Price : $8.95]
Federal Register notice: FDA extends the comment period on a 9/8 notice seeking input on existing regulations and related paperwor...[ Price : $8.95]
FDA accepts for review an Insys Therapeutics NDA for what it calls a novel formulation of buprenorphine as a sublingual spray for ...[ Price : $8.95]
The Supreme Court asks the Solicitor General to provide the governments view on Mercks appeal of a 3rd Circuit decision involving ...[ Price : $8.95]
FDA warns Hand Biomechanics about Medical Device Reporting and Quality System Regulation violations in its manufacturing of bone f...