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Tobacco Center Seeks Tours Program Participants

10/07/2014

Federal Register Notice: FDA’s Center for Tobacco Products’ (CTP) Office of Science is inviting participants for its L...

Info on Orphan Drug Application Forms Sent to OMB

10/07/2014

Federal Register Notice: FDA’s proposed collection of information, “Orphan Drugs; Common European Medicines Agency/Foo...

OMB OKs Info Collection on Drug/Biologic User Fees

10/07/2014

Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on User Fee Waivers, Reductio...

Guidance on Breast Cancer Neoadjuvant Treatment Trials

10/07/2014

Federal Register Notice: FDA is making available guidance for industry entitled Pathological Complete Response in Neoadjuvant Trea...

Guidance on Cybersecurity in Devices

10/02/2014

Federal Register Notice: FDA is making available a guidance: Content of Premarket Submissions for Management of Cybersecurity in M...

Rate Set for Rare Pediatric Priority Review

10/01/2014

Federal Register Notice: FDA is announcing the fee rate at $2,562,000 for using a rare pediatric disease priority review voucher f...

Custom Device Exemption Guidance

09/24/2014

Federal Register Notice: FDA is making available a guidance entitled Custom Device Exemption. The agency defines terms used in the...

Veterinary ICH Guidance on Blood Level Bioequivalence

09/24/2014

Federal Register Notice: FDA is making available Draft Guidance for Industry, Bioequivalence: Blood Level Bioequivalence Study (VI...

FDA Corrects Notice on Lot Distribution Report Guidance

09/16/2014

Federal Register Notice: FDA is correcting an 8/29 notice entitled “Draft Guidance for Industry: Electronic Submission of Lo...

Info on Health & Diet Surveys Sent to OMB

09/10/2014

Federal Register Notice: FDA’s proposed collection of information, “Health and Diet Survey as Used by the Food and Dru...