Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Pediatric Study Delays Could Draw Civil Penalties Under Proposal For PREA, BPCA Reauthorization

This article was originally published in The Pink Sheet Daily

Executive Summary

Civil penalties would be more flexible than FDA’s current authority to label a drug misbranded if sponsors fail to conduct pediatric studies, Commissioner Hamburg argues as the House Energy and Commerce Committee’s Health Subcommittee opens hearings on reauthorizing prescription drug user fees.

You may also be interested in...

Pediatric Study Plans Would Be Required At End Of Phase II Under Bipartisan House Bill

Rather than assessing monetary penalties for violating study deadlines, H.R. 4274 directs FDA to issue warning letters and publish them on its website.

FDA Pediatric Incentives, Powers Would Become Permanent Under Draft Bill

In the absence of sunset provisions that necessitate periodic reauthorization of the pediatric laws, GAO would report to Congress on a five-year cycle about the accomplishments of the drug programs for children and make recommendations for amendments.

Exclusivity For Biologics, Drugs Should Be The Same After All, Grabowski Says

Duke University economics professor Henry Grabowski and his colleagues suggest the Hatch-Waxman statute be revised to mirror biosimilars legislation and provide 12 years of market exclusivity.

Related Content





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts