Pediatric study bill
This article was originally published in The Tan Sheet
Executive Summary
FDA's authority to require drug sponsors to conduct trials in children would expire at the same time as the pediatric exclusivity incentive program under a bill passed by the Senate July 23. Amendment to S 650 makes the bill applicable to all NDAs submitted "on or after April 1, 1999," the same date FDA's pediatric rule first took effect. Amendment also explains how deferral or waivers granted by FDA would apply retroactively. American Academy of Pediatrics supported amendment, but opposed the bill along with Democratic Sens. Christopher Dodd (Conn.), Hillary Clinton (N.Y.), Edward Kennedy (Mass.)...
You may also be interested in...
Pediatric Research Equity Act
S 650 "will provide FDA with additional authority to require pediatric studies of pharmaceutical products when such studies are needed to ensure the safe and effective use of the products in children," agency notes in Nov. 19 release. Bill was presented to President Bush Nov. 21. An amendment linking the expiration of the S 650 to the pediatric exclusivity incentive program remains in the bill (1"The Tan Sheet" Aug. 4, 2003, In Brief)...
Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer
Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025. It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.
Xaira Launches With $1bn-Plus And End-To-End AI Strategy
ARCH and Foresite incubated the company and recruited Genentech R&D veteran Marc Tessier-Lavigne to keep data generation, machine learning research and drug development under one roof.