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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Federal Register Notice: FDA is making available Draft Guidance for Industry, Bioequivalence: Blood Level Bioequivalence Study (VI...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Federal Register Notice: FDA is correcting an 8/29 notice entitled “Draft Guidance for Industry: Electronic Submission of Lo...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...

FDA Corrects Rule on BLA Safety Test Requirements

09/10/2014

Federal Register Proposed rule: FDA is correcting a proposed rule entitled “Revocation of General Safety Test Regulations Th...

OMB OKs Info on Testing Communications on Biologics

09/10/2014

Federal Register Notice: FDA’s collection of information entitled “Testing Communications on Biological Products&rdquo...

Guidance on Unique Device ID System

09/10/2014

Federal Register Notice: FDA is making available a guidance for industry, Unique Device Identification System: Small Entity Compli...

Dengue Virus Tests into Class 2

09/10/2014

Federal Register Final order: FDA is classifying dengue virus nucleic acid amplification test reagents into Class 2 (special contr...

Comments Sought on Supplement GMP Info

12/19/2013

Federal Register Notice: FDA is seeking public comment on the information collection provisions of FDA’s current good manufa...

Comments Sought on Tobacco Substantial Equivalence Requirements

12/19/2013