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

Generic Drug Liability: Harvard Researchers Propose New Adverse Events Database, Compensation Fund

This article was originally published in The Pink Sheet Daily

Executive Summary

Jerry Avorn and his colleagues suggest that a new database be created at FDA to be managed by the agency’s Sentinel program, PCORI or another organization; they also recommend development of a “consensus label” and a minimum Rx fee to fund pharmacovigilance.

You may also be interested in...



Supreme Court To Reconsider “Rules Of the Road” In Generic Preemption

Design defect claims made against generic companies are focus of a case involving Mutual Pharmaceutical’s generic sulindac; ruling may eliminate lower court carve-outs to its Mensing decision.

Generics Liability Bill Could Face Uphill Road In Senate

Sen. Leahy plans to introduce legislation to overturn the Supreme Court’s ruling in Pliva v. Mensing; the attorney who represented generic manufacturers in that case says the legislation is unlikely to pass.

Generic Firms Get Supreme Shield From Product Liability, But Court Hints At Reg Change

In Pliva v. Mensing, the high court said it was impossible for generic manufacturers to comply with both state tort laws and FDA regulations requiring them to have the same labels as those for brand name counterparts.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS073453

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