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Info On Postmarket Surveillance Sent to OMB

09/08/2016

Federal Register Notice: FDA’s proposed collection of information “Postmarket Surveillance — 21 CFR Part 822,&rd...

Comments Sought on Device Recordkeeping Requirements

09/08/2016

Federal Register Notice: FDA seeks comments on recordkeeping requirements related to the medical devices current good manufacturin...

FDA Renews Oncologic Drugs Panel

09/08/2016

Federal Register Notice: The FDA commissioner is renewing the charter of the Oncologic Drugs Advisory Committee for an additional ...

Prevacid IV Not Withdrawn For S&E

09/08/2016

Comments Sought on Vinpocetine

09/07/2016

Federal Register Notice: FDA is requesting comments related to the regulatory status of vinpocetine. The agency seeks comments on ...

Info on Clinical Laboratory Improvement Amendments

09/07/2016

Federal Register Notice: FDA’s proposed collection of information, “Requests for Clinical Laboratory Improvement Amend...

Comments Sought on HCT/P Regulations

09/07/2016

Federal Register Notice: FDA is seeking comments on the information collection requirements for agency regulations related to huma...

FDA Issues Emergency Use Authorization for Zika Diagnostic

09/07/2016

Federal Register Notice: FDA is issuing an Emergency Use Authorization for a Viracor-IBT Laboratories’ in vitro diagnostic d...

Comments Sought on Device Fellowship Program

09/06/2016

Federal Register Notice: FDA is seeking public comment on the application for participation in the Medical Device Fellowship Progr...

Info on Product Jurisdiction Sent to OMB

09/06/2016

Federal Register Notice: FDA’s proposed collection of information, “Product Jurisdiction: Assignment of Agency Compone...