02/23/2007
Federal Register Notice: FDA has determined the regulatory review period for Medtronic Vascular’s S8 Over-the-Wire System is...02/23/2007
Federal Register Notice: FDA is withdrawing approval of 128 suitability petitions in accordance with the Pediatric Research Equity...02/23/2007
Federal Register Notice: FDA has determined the regulatory review period for Bristol-Myers Squibb’s Baraclude (entecavir) is...02/23/2007
Federal Register Notice FDA has determined the regulatory review period for Sucampo AG’s Amitiza is 2,197 days for the exten...02/22/2007
Federal Register Request for data and information: FDA is seeking information to formulate a regulatory position on insect repelle...02/22/2007
Federal Register Notice: FDA has determined the regulatory review period for Novo Nordisk’s Levemir (insulin determir (rDNA ...02/20/2007
“There should be no confusion about who FDA serves … It’s important to get drugs rapidly to market, but rapid d...02/16/2007
[Commentary by Robert Steeves*] FDA’s relations with the Congress have not been as fractured as they are today in more than ...