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Federal Register Notice: FDA is making available a draft guidance, Pharmacogenomic Data Submissions — Companion Guidance.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

Guidance on Decorative/Non-corrective Contacts

11/27/2006

Federal Register Notice: FDA is making available a document entitled Guidance for Industry, FDA Staff, Eye Care Professionals, an...

Dispute Panel to Discuss Acorn Device

11/27/2006

Federal Register Notice: FDA’s Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee will meet...

Comments Sought on E-submissions to CVM

11/08/2006

Federal Register Notice: FDA is seeking comments on extending Office of Management and Budget (OMB) approval on the existing repo...

Comments Sought on E-mailing a Study Protocol

11/08/2006

Federal Register Notice: FDA is seeking public comment on extending OMB approval of existing reporting requirements for the infor...

Comments Sought on Electronic Meetings Requests with CVM

11/08/2006

Federal Register Notice: FDA is seeking comments on extending Office of Management and Budget (OMB) approval of existing reportin...