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FDA Withdraws 70 NDAs and 97 ANDAs

06/08/2011

Federal Register Notice: FDA is withdrawing approval of 70 NDAs and 97 ANDAs from multiple applicants. The holders of the applicat...

FDA To Collaborate on International Vaccines/Biologics

06/06/2011

Federal Register Notice: FDA intends to accept and consider a single source application for awarding a cooperative agreement to th...

Comments Sought on Prescription Drug Marketing Act Requirements

06/06/2011

Federal Register Notice: FDA is seeking public comment on a proposed collection of information on the reporting and recordkeeping ...

Orlaam Not Withdrawn For S&E

06/06/2011

Federal Register Notice: FDA has determined that Roxane Labs’ Orlaam (levomethadyl acetate hydrochloride (HCl)) oral solutio...

Notice on Clinical Investigator Guidance Corrected

06/06/2011

Federal Register Notice: FDA is correcting a docket number in a 5/24 Federal Register notice that announced the availability of a ...

Panel to Discuss Remicade Clinical Trial

06/03/2011

Federal Register Notice: FDA’s Gastrointestinal Drugs Advisory Committee will meet 7/21, from 8 a.m. to 4 p.m. at the Hilton...

Comments Sought on Supplement Claim Substantiation

06/03/2011

ICH Guidance on Veterinary Drug Residues in Human Food

06/03/2011

Federal Register Notice: FDA is making available a draft revised guidance for industry, Studies to Evaluate the Safety of Residues...

Tobacco Committee to Meet

06/03/2011

Info on Drug Product Communications Sent to OMB

06/03/2011