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FDA Puts Multiplex Test Instrumentation into Class II

03/10/2005

Federal Register Final rule: FDA is classifying instrumentation for clinical multiplex test systems into Class II (special control...

Genotyping Tests Go Into Class II

03/10/2005

Federal Register Final rule: FDA is classifying drug metabolizing enzyme (DME) genotyping test systems into Class II (special cont...

List of Approved PMAs Available

03/10/2005

Federal Register Notice: FDA is publishing a list of premarket approval applications (PMAs) that have been approved to inform the ...

FDA Sends Info on Corrections and Removals Reports to OMB

03/04/2005

Federal Register Notice: FDA’s proposed collection of information entitled “Reports of Corrections and Removals —...

Info on Customer/Partner Service Surveys Sent to OMB

03/04/2005

Federal Register Notice: FDA’s proposed collection of information entitled “Customer/Partner Service Surveys” ha...

FDA Sends Device Tracking Info to OMB

03/04/2005

Federal Register Notice: FDA’s proposed collection of information entitled, “Medical Devices; Device Tracking — ...

FDA Withdraws Approval of 76 NDAs, 60 ANDAs

03/04/2005

Federal Register Notice: FDA is withdrawing approval of 76 NDAs and 60 ANDAs from multiple applicants. The holders of the applicat...

FDA Reports on Postmarketing Studies

02/18/2005

Federal Register Notice: FDA is making its annual report on the status of postmarketing study commitments made by sponsors of appr...

Guidance on Clinical Safety Review of a New Application

02/18/2005

Federal Register Notice: FDA is making available a review guidance entitled Conducting a Clinical Safety Review of a New Product A...

Guidance on Developing Plasmid DNA Vaccines

02/18/2005

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Considerations for Plasmid DNA V...