Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

UsernamePublicRestriction

Ain’t That A Sham: US House Bill Tries To Thread The Needle On Citizen Petitions

Executive Summary

For years, brand industry critics have decried the use of “sham” citizen petitions to delay generic drug approvals. But one person’s “sham” is another person’s First Amendment right to petition the government. A House bill tries to thread that needle.

You may also be interested in...



House Judiciary Committee Advances Four Drug Pricing Bills, Although Changes Are Still Likely

US committee will likely re-examine the language regarding the burden of proof in a bill prohibiting pay-for-delay settlements.

Indivior Knew Suboxone Film Did Not Have Greater Child Safety Than Tablet, Grand Jury Claims

Indictment alleges Indivior falsely cited concerns about pediatric exposure to tablets in discontinuing the formulation; FDA official says company tried to mislead agency and bar competition for Suboxone.

REMS Abuse Website: Has It Changed The Behavior Of Innovators?

Updated numbers from the US FDA's REMS abuse website show that Celgene has received two additional safety determination letters, raising question's about whether the public list has changed the practices of brand companies hindering generic company access to samples.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS125261

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

Cancel