06/08/2009
Federal Register Notice: FDA is making available additional draft and revised draft product-specific bioequivalence (BE) recommend...06/08/2009
Federal Register Notice: FDA is seeking public comment on Form FDA 3397, User Fee Cover Sheet, that must be submitted along with c...06/08/2009
Federal Register Notice: FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet 7/28 from 8 a.m. to 5 p.m. at the...06/05/2009
Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for a NADA for fomepizole ...05/27/2009
Federal Register Notice: FDA is making available a draft guidance for industry, Presenting Risk Information in Prescription Drug a...05/27/2009
Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for luprostiol injectable ...05/18/2009
Ortho-Biotech has asked FDA to adopt bioequivalence requirements including clinical trials to govern approval of any ANDA or 505(b...12/18/2008
Federal Register Notice: FDA’s Office of Orphan Product Development (OPD) is providing notice of a funding opportunity annou...