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OMB OKs Info On Device Labeling Regs

10/23/2015

Federal Register Notice: FDA’s collection of information entitled “Medical Device Labeling Regulations” has been...

Guidance on Package Types for Injectable Products

10/22/2015

Federal Register Notice: FDA is making available a draft guidance for industry entitled Selection of the Appropriate Package Type ...

OMB OKs Info on Formal Evidentiary Hearing

10/21/2015

Federal Register Notice: FDA’s collection of information entitled “Administrative Practices and Procedures; Formal Evi...

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Federal Register Notice: FDA is making available a draft guidance entitled Manufacturing Site Change Supplements: Content and Subm...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