Full Pediatric Labeling Is Lacking For One Third Of Orphan Drugs, US FDA Finds
Executive Summary
The past three years have seen an increase in number of orphan drug labels containing appropriate pediatric information.
You may also be interested in...
Sharfstein: US FDA Incentives Not Broke, But Fix Them
The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.
Pediatric Studies: Industry Seeks Narrower, More Timely Requests From US FDA
PhRMA asks FDA to consider expiration of pediatric exclusivity in requesting pediatric clinical trials; AbbVie describes eight-year effort to begin enrollment in Humira pediatric ulcerative colitis study.
US FDA’s Median Review Time For Novel Drugs Held Steady In 2020
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: