Recommendations on how to interpret the requirements of the Pediatric Research Equity Act are included in a FDL-1draft guidance published in the Federal Register Sept. 7. The Act, which became law in December 2003, requires studies to be conducted in drugs that will be frequently used by children to assure that the products bear adequate pediatric labeling. PREA does not impose study requirements on abbreviated new drug applications that do not propose a new indication, new dosage form or new route of administration, the draft guidance notes. The document also states that the type of data required for submission "will depend on the nature of the application [and] what is known about the product in pediatric populations." For example, pediatric effectiveness could be extrapolated from "adequate and well-controlled studies in adults" if the disease and its treatment are similar in adult and pediatric populations. Comments are due Nov. 7...
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.
Expanded funding for cost recovery could dovetail with FDA Commissioner Martin Makary’s idea for a “conditional approval” pathway based on a plausible mechanism of action.
A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.
