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Review Period Set for Xience Stent System

06/10/2014

Federal Register Notice: FDA has determined the regulatory review period for Abbott Cardiovascular Systems’ Xience Prime Ll ...

Grant Funds Available for Kidney Initiative

06/10/2014

Federal Register Notice: FDA is making available grant funds to support CDER/Office of Medical Policy’s Kidney Health Initia...

Dispute Panel Canceled

06/10/2014

Federal Register Notice: The meeting of the Medical Devices Dispute Resolution Panel scheduled for 6/10 is cancelled. It was annou...

FDA Requires Electronic Safety Reports

06/10/2014

Federal Register Final rule: FDA is amending its postmarketing safety reporting regulations for human drug and biological products...

Guidance on Electronic Postmarketing Safety Reports

06/10/2014

Federal Register Notice: FDA is making available a draft guidance for industry entitled Providing Submissions in Electronic Format...

OMB OKs Info on Safety Assurance

06/09/2014

Federal Register Notice: FDA’s collection of information entitled “Safety Assurance Case” has been approved by t...

Panel to Discuss Morcellator Devices

06/09/2014

Federal Register Notice: FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet 7...

Info on Biological Product Communications Sent to OMB

06/09/2014

Federal Register Notice: FDA’s proposed collection of information, “Testing Communications on Biological Products,&rdq...

Workshop on 3-D Printing

05/19/2014

Federal Register Notice: FDA will hold a public workshop 10/8-9: “Additive Manufacturing of Medical Devices: An Interactive ...

Review Period Set for Elelyso

05/19/2014

Federal Register Notice: FDA has determined the regulatory review period for Protalix Ltd.’s Elelyso (taliglucerase alfa) is...