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OMB OKs Info on Export Certificates

07/22/2009

Federal Register Notice: FDA’s collection of information, “Export of Food and Drug Administration Regulated Products: ...

Prescription Drug Marketing Act Info Sent to OMB

07/22/2009

Federal Register Notice: FDA’s proposed collection of information, “Prescription Drug Marketing Act of 1987; 21 CFR Pa...

Orphan Products Has Funding Opportunity

12/18/2008

Federal Register Notice: FDA’s Office of Orphan Product Development (OPD) is providing notice of a funding opportunity annou...

FDA OKs Elanco Animal Health sNADA for Swine

12/18/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of two Elanco Animal Health supplemen...

Comments Sought on DTC Coupons

12/15/2008

Federal Register Notice: FDA is seeking public comment on a study of the impact coupons offering price incentives or rebates have ...

Risk Panel to Discuss Info Available to Patients

12/08/2008

Federal Register Notice: FDA’s Risk Communication Advisory Committee will meet 2/26, from 8 a.m. to 5 p.m. and 2/27, from 8 ...

Guidance on Data Retention on Withdrawn Trial Participants

12/01/2008

Federal Register Notice: FDA is making available a guidance, Data Retention When Subjects Withdraw from FDA-Regulated Clinical Tri...

Time Changed on Pediatric Ethics Subcommittee Meeting

12/01/2008

Federal Register Notice: FDA is amending an 11/14 notice of a meeting of its Pediatric Ethics Subcommittee of the Pediatric Adviso...

FDA OKs Elanco Animal NADA for turkey feed

12/01/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of an Elanco Animal Health NADA that ...

FDA Revokes Cephalosporin Prohibition

11/26/2008

Federal Register Final rule: FDA is revoking the order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food...