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Change of Sponsor for 54 NADAs, 14 ANADAs

07/26/2016

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal...

Biliary Stent System into Class 2

07/13/2016

Federal Register Final order: FDA is classifying the metallic biliary stent system for benign strictures into Class 2 (special con...

Guidance on Benefit-Risk Considerations for Device Enforcement

06/16/2016

Federal Register Notice: FDA is making available a draft guidance entitled Factors to Consider Regarding Benefit-Risk in Medical D...

Guidance on ISO Biological Evaluation of Devices

06/16/2016

Federal Register Notice: FDA is making available a guidance entitled Use of International Standard ISO 10993-1, `Biological evalua...

Pediatric Clinical Investigator Workshop

06/16/2016

Federal Register Notice: FDA’s Office of Pediatric Therapeutics, and the Eunice Kennedy Shriver National Institute of Child ...

Pediatric Oncology Subcommittee to Meet

06/16/2016

Federal Register Notice: FDA will hold a meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee6...

Comments Sought on Biologic and HCT/P Deviations Reporting

06/07/2016

Federal Register Notice: FDA is seeking public comment on the information collection requirements relating to the reporting of bio...

FDA Issues EUA for Zika Diagnostic

04/22/2016

Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for detecting Zika virus ...

Hearing on HCT/P Draft Guidances

04/22/2016

Federal Register Notice: FDA will hold a two-day public hearing 9/12-13 to obtain input on four draft guidance documents relating ...

Comments Sought on Unapproved Device Exportation

04/22/2016

Federal Register Notice: FDA is seeking public comments on reporting requirements for firms that intend to export certain unapprov...