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Comments Sought on Device User Fee Form

10/21/2015

Federal Register Notice: FDA is seeking public comment on a proposed collection of information on the Form FDA 3601, entitled &ldq...

Comments Sought on Supplement AERs/Recordkeeping Info

10/21/2015

Federal Register Notice: FDA is seeking public comments on the collection of information associated with adverse event reporting a...

Info on Reducing Tobacco Use Sent to OMB

10/21/2015

Federal Register Notice: FDA’s proposed collection of information, “Evaluation of FDA’s Campaign To Reduce Tobac...

Comments Sought on Requesting CDRH Review of Decisions

10/21/2015

Federal Register Notice: FDA is seeking public comments on information collection associated with the processes available to outsi...

Comments Sought on Device Inspection Accredited Persons

10/21/2015

Federal Register Notice: FDA is seeking public comments on a proposed collection of information, “Inspection by Accredited P...

Guidance on Device Manufacturing Site Change Supplements

10/21/2015

Federal Register Notice: FDA is making available a draft guidance entitled Manufacturing Site Change Supplements: Content and Subm...

Panel Meets on BioMarin NDA for Duchenne Muscular Dystrophy

10/15/2015

Federal Register Notice: FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will meet 11/24, from 8 a.m. t...

Comments Reopened on PDUFA Reauthorization

10/14/2015

Federal Register Notice: FDA is reopening until 4/29/16 the comment period for the notice of public meeting that appeared in the 5...

Guidance on Animal Studies for Medical Devices

10/14/2015

Federal Register Notice: FDA is making available a draft guidance entitled General Considerations for Animal Studies for Medical D...

Guidance on Microbial Vectors Used for Gene Therapy

10/14/2015

Federal Register Notice: FDA is making available a draft document entitled Recommendations for Microbial Vectors Used for Gene The...