07/29/2009
Federal Register Notice: FDA has determined the regulatory review period for Senju Pharmaceutical’s Durezol is 560 days for ...07/29/2009
Federal Register Notice: FDA has determined the regulatory review period for Kissei Pharmaceutical’s Rapaflo is 3,681 days f...07/22/2009
Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for three NADAs and one ab...07/22/2009
Federal Register Notice and Final rule: FDA is withdrawing approval of two NADAs (Wellmark International’s Zodiac Fleatrol F...07/22/2009
Federal Register Notice: FDA’s collection of information, “Guidance for Clinical Trial Sponsors: Establishment and Ope...07/22/2009
Federal Register Notice: FDA’s collection of information entitled “Notice of Participation” has been approved by...07/22/2009
Federal Register Notice: FDA’s collection of information, “Export of Food and Drug Administration Regulated Products: ...07/22/2009
Federal Register Notice: FDA’s proposed collection of information, “Prescription Drug Marketing Act of 1987; 21 CFR Pa...