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Federal Register Notice: FDA is making available a draft guidance entitled Manufacturing Site Change Supplements: Content and Subm...

FDA Plans Conference on Drug-Induced Liver Injuries

12/19/2014

Federal Register Notice: FDA will hold a public conference 3/18-19/15 entitled “Serious Drug-Induced Liver Injury (DILI): Th...

Info on Form FDA 3674 Sent to OMB

12/19/2014

Federal Register Notice: FDA’s proposed collection of information, “Certification To Accompany Drug, Biological Produc...

Public Meeting on Breast Cancer Drug Development

12/19/2014

Federal Register Notice of public meeting: FDA will hold a public meeting 4/2 on patient-focused drug development for breast cance...