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Comments Sought on Device Innovation Report

02/09/2011

Federal Register Notice: FDA is making available for comment a report entitled “Medical Device Innovation Initiative.”...

FDA Plans Device Innovation Public Workshop

02/09/2011

Federal Register Notice: FDA will hold a public meeting 3/15 entitled “CDRH's Medical Device Innovation Initiative Public Wo...

FDA Sends Info on Device Fellowship Program to OMB

01/27/2011

Federal Register Notice: FDA has submitted a proposed collection of information, “Application for Participation in the Medic...

OMB OKs Info on Tobacco Communications

01/27/2011

Federal Register Notice: FDA’s collection of information, “Pre-testing of Tobacco Communications,” has been appr...

Conference on Drug-Induced Liver Injury

01/27/2011

Federal Register Notice: FDA will co-sponsor with PhRMA and the American Association for the Study of Liver Diseases a public conf...

CBER Announces Site Training Program

01/27/2011

Federal Register Notice: CBER is inviting interested parties to participate in its Regulatory Site Visit Training Program intended...

Comments Sought on S&E Clinical Trials

01/27/2011

Federal Register Notice: FDA is seeking comments on requirements for safety and effectiveness clinical investigations of unapprove...

OMB OKs Info on Device Premarket Approval

01/27/2011

Federal Register Notice: FDA’s collection of information, “Premarket Approval of Medical Devices.” has been appr...

Tobacco Panel to Meet

01/26/2011

Federal Register Notice: FDA’s Tobacco Products Scientific Advisory Committee will meet 3/1-2, from 8 a.m. until 5 p.m. at t...

Guidance on Process Validation

01/25/2011

Federal Register Notice: FDA is making available a guidance for industry, Process Validation: General Principles and Practices. It...