HBW Insight 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

Senate Health Committee Plans To Codify FDA Generic Drug Proposal

This article was originally published in The Tan Sheet

Executive Summary

The Senate Health & Education Committee plans to codify FDA's Hatch/Waxman reform proposal after the final rule is issued

You may also be interested in...



Hatch/Waxman Reform Bill Needed Despite FDA Rule – McCain, Schumer

Legislation to reform the generic drug approval process will still be needed following issuance of FDA's final rule, Sens. John McCain (R-Ariz.) and Charles Schumer (D-N.Y.) said

Hatch/Waxman Reinterpretation Underpins Change In 30-Month Stay Policy

FDA's proposal to allow only one 30-month stay of approval for ANDAs hinges on a reinterpretation of Hatch/Waxman language declaring that patent holders must be notified if a generic application is amended to "include" a Paragraph IV certification

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS128943

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