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FDA Proposes cGMPs for Combination Products

09/23/2009

Federal Register Proposed rule: FDA proposes to codify the current good manufacturing practice (cGMP) requirements applicable to c...

Guidance on Therapeutic Cancer Vaccines

09/18/2009

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Clinical Considerations for Ther...

ICH Prep Meeting Slated

09/18/2009

Federal Register Notice: FDA will hold a public meeting 10/14 entitled “Preparation for ICH meetings in St. Louis, Missouri&...

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 ...

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 ...

Guidance on Data Retention on Withdrawn Trial Participants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...