08/01/2008
Federal Register Notice: FDA is publishing the fee rates and payment procedures for medical device user fees for fiscal year 2009....08/01/2008
Federal Register Notice: FDA is publishing the rates for prescription drug user fees for fiscal year 2009. Application fees for an...07/21/2008
Federal Register Notice: FDA will sponsor a public workshop 9/15 to discuss the issues associated with developing and implementing...07/10/2008
[Report by John Scharmann*] Has FDA Office of Enforcement director David Elder added a new industry warning tool to his armory? It...07/10/2008
[Commentary by Jim Dickinson*] With newspaper circulations tumbling throughout the nation, and TV news viewership also in decline,...07/10/2008
Federal Register Notice: FDA is making available a draft guidance for industry, Voluntary Third-Party Certification Programs for F...07/10/2008
Federal Register Final rule: FDA is amending its regulations on NDAs and ANDAs by discontinuing its use of approvable letters and ...07/07/2008
Federal Register Notice: FDA is seeking pharmaceutical firm volunteers to participate in a pilot program on the submission of qual...