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Panel to Discuss Spectrum Pharma NDA

07/28/2016

Federal Register Notice: FDA will hold a meeting of the Oncologic Drugs Advisory Committee 9/14, from 8 a.m. to 1 p.m. at the FDA ...

FDA Posts Generic Drug User Fee Rates

07/27/2016

Federal Register Notice: FDA is announcing the rates for ANDAs ($70,480), prior approval supplements to an approved ANDA ($35,240)...

Guidance on Real-World Evidence to Support Device Decisions

07/27/2016

Federal Register Notice: FDA is making available a draft guidance: Use of Real-World Evidence to Support Regulatory Decisionmaking...

Guidance on Device Adaptive Clinical Study Designs

07/27/2016

Federal Register Notice: FDA is making available a guidance entitled Adaptive Designs for Medical Device Clinical Studies. It prov...

Panel to Discuss Southern Hemisphere Influenza Vaccine

07/27/2016

Federal Register Notice: FDA will hold a meeting 10/13 of the Vaccines and Related Biological Products Advisory Committee. The com...

FDA Sends Info on Tobacco Health Education to OMB

07/26/2016

Federal Register Notice: FDA’s proposed collection of information, “Requirements Under the Comprehensive Smokeless Tob...

FDA Posts Modifications to Device Standards

07/26/2016

Federal Register Notice: FDA is releasing a publication containing modifications it is making to the list of standards the agency ...

Guidance on Unique Device ID System

07/26/2016

Federal Register Notice: FDA is making available a draft guidance for industry and FDA staff entitled Unique Device Identification...

FDA Reclassifies Iontophoresis Devices into Class 2

07/26/2016

Federal Register Final order: FDA is issuing a final order to reclassify iontophoresis devices intended for any other purposes, wh...

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...