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Federal Register Notice: FDA is making available a draft guidance for industry, Voluntary Third-Party Certification Programs for F...07/10/2008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...07/07/2008
Federal Register Notice: FDA is requesting submission of data related to certain recommendations in the draft guidance, Draft Guid...07/07/2008
Federal Register Notice: FDA is making available the information technology plan, “Prescription Drug User Fee Act (PDUFA) IV...06/23/2008
Federal Register Notice: FDA has determined the regulatory review period for Eli Lilly’s Eraxis is 3,476 days for the purpos...06/23/2008
Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor's drug labeler code for AD...