Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Accelerated Approval Should Be Less 'Wide Open,' Califf Says

Related Content

Accelerated Approval May Support Smaller Trials In Acute Diseases – FDA

Jun 02 2014

Accelerated Approval After Eteplirsen: A Lowered Bar Or A Unique Event?

Sep 21 2016

Sarepta's Eteplirsen Approved After Contentious Internal FDA Debate

Sep 20 2016

FDA's Breakthrough Workload Will Be Eased By Hiring Reviewers With PDUFA VI Funds

Jul 21 2016

Rare Disease Integration Into FDA Reviews Will Grow Under PDUFA VI

Jul 18 2016

Political Appointees Shouldn't Influence Approval Decisions, Califf Says

Oct 20 2016

No More Sarepta-Like Development, FDA Officials Say

Oct 20 2016

Regulatory Flexibility Staring Contest: Will Industry Or FDA Blink First?

Oct 24 2011

Related Companies

Sarepta Therapeutics, Inc.

BioMarin Pharmaceutical Inc.

PTC Therapeutics, Inc.

Additional Topics

United States Drug Approval Standards Review Pathway Clinical Trials Drug Review Policy BioPharmaceutical

More from Approval Standards

More from Pathways & Standards

About Us

Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us

Customer Service
SubscribeOpens in new window
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window