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Mammography Advisory Committee to Meet

09/11/2007

Federal Register Notice: FDA’s National Mammography Quality Assurance Advisory Committee will meet 11/5, from 9 a.m. to 5 p....

Pharmacogenomic Data Submissions Guidance Out

08/29/2007

Federal Register Notice: FDA is making available a draft guidance, Pharmacogenomic Data Submissions — Companion Guidance. Th...

Orphan Drugs Info OK’d by OMB

08/29/2007

Federal Register Notice: FDA’s collection of information, “Orphan Drugs” has been approved by the Office of Mana...

FDA Corrects Info on ICH Prep Meeting

08/27/2007

Federal Register Notice: FDA is correcting an 8/13 Federal Register notice that announced a public meeting entitled “Prepara...

FDA Proposes OTC Sunscreen Monograph Change

08/27/2007

Federal Register Proposed rule: FDA is proposing to amend the final monograph for OTC sunscreen drug products as part of the agenc...

Comments Sought on Type A Medicated Articles Recordkeeping

08/16/2007

Federal Register Notice: FDA is seeking public comment on the recordkeeping requirements for current good manufacturing practice (...

FDA Proposes Blood Reg Updates

08/16/2007

Federal Register Proposed rule and direct final rule: FDA is proposing to amend the biologics regulations by removing, revising, o...

Comments Sought in Medicated Feed Recordkeeping

08/16/2007

Federal Register Notice: FDA is seeking comments on the recordkeeping requirements for current good manufacturing practice regulat...

Panels to Discuss Children’s Cold Products

08/16/2007

Federal Register Notice: FDA’s Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee will meet 10/18-19,...

FDA Sends Info on Communicable Disease Curbs to OMB

08/15/2007

Federal Register Notice: FDA has sent a proposed collection of information, “Control of Communicable Diseases; Restrictions ...