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Comments Sought on IVD Device Studies Guidance

10/23/2015

Federal Register Notice: FDA is seeking public comments on guidance on informed consent for in vitro diagnostic device studies usi...

OMB OKs Info on Device Recall

10/23/2015

Federal Register Notice: FDA’s collection of information entitled “Medical Device Recall Authority” has been app...

OMB OKs Info on MedWatch

10/23/2015

Federal Register Notice: FDA’s collection of information entitled “MedWatch: The Food and Drug Administration Medical ...

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Federal Register Notice: FDA is making available a draft guidance for industry entitled Selection of the Appropriate Package Type ...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