USFDA : Social Media Promotion !!! OPDP Reopens Comment Period for Two Draft Social Media Guidances...

In response to a request for additional time and to allow interested persons more time to submit comments, FDA is reopening the comment period for the two draft social media guidances that published on June 17, 2014.

Beginning September 29, 2014, the public will have an additional 30 days to provide comments on the draft guidances—“Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices” and “Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices.”

To view USFDA's Social Media Guidances Webpage CLICK HERE

USFDA : Draft Guidance for Industry : Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices

A draft guidance has been posted titled, "Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices."  FDA is issuing this guidance to provide industry and agency staff with recommendations for 100 the suggested format and content of an Abbreviated 510(k) submission for early growth 101 response 1 (EGR1) gene fluorescence in-situ hybridization (FISH) test system for specimen 102 characterization devices and recommendations for addressing certain labeling issues relevant 103 to the review process specific to these devices.  

To view/download the draft guidance, please CLICK HERE