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Home > New FDA Approvals > 036 - FDA grants fast track designation to elamipretide for Barth syndrome; FDA begins adding suffixes to newly approved biologics' names; FDA proposes to limit risk info in DTC advertisements
Podcast: New FDA Approvals
Episode:

036 - FDA grants fast track designation to elamipretide for Barth syndrome; FDA begins adding suffixes to newly approved biologics' names; FDA proposes to limit risk info in DTC advertisements

Category: Science & Medicine
Duration: 00:08:12
Publish Date: 2017-11-28 07:00:00
Description:

November 28, 2017

0:30 Stealth BioTherapeutics Granted Fast Track Designation for the Treatment of Barth Syndrome

http://www.stealthbt.com/stealth-biotherapeutics-granted-fast-track-designation-treatment-barth-syndrome/

2:12 FDA begins adding suffixes to newly approved biologics' names

http://www.pharmacist.com/article/fda-begins-adding-suffixes-newly-approved-biologics-names

https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm459987.pdf

4:02 Stakeholders Weigh FDA Proposal to Limit Risk Info in DTC Advertisements

http://raps.org/Regulatory-Focus/News/2017/11/27/28924/Stakeholders-Weigh-FDA-Proposal-to-Limit-Risk-Info-in-DTC-Advertisements/

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