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 bill

Executive Summary

Senate Health Committee adopts Sen. Hillary Clinton's (D-N.Y.) mandatory pediatric research bill Aug. 1 by voice vote. The bill (S 2394) would codify FDA's authority to require pediatric studies from sponsors and award six months exclusivity. Final language does not include an amendment proposed by Sen. Christopher Bond (R-Mo.) that would have awarded three months additional exclusivity for a second round of pediatric studies (1"The Pink Sheet" July 29, p. 11)...

You may also be interested in...

Pediatric Exclusivity Expansion Floated On Hill; Mandatory Study Bill Pending

An additional three months of exclusivity would be awarded for a company's second round of pediatric studies under a proposed amendment to Sen. Hillary Rodham Clinton's (D-N.Y.) bill to codify FDA's mandatory pediatric study rule

No Eudamed, No Problem! Latest Guidance Explains Alternatives While Database Is Built

Lack of official explanation about how the exchange of critical information will progress pending the launch of the EU’s medical device database, Eudamed3, has left many confused. New guidance lights the way forward.

David Now Goliath? Made In China PD-1s Sought After By Multinationals

From relatively little-known to high-flying, hotly pursued targets by global pharma players, Chinese domestically developed immuno-oncology drugs are ascending in both value and attractiveness, both inside China and far beyond.




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