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

UsernamePublicRestriction
UsernamePublicRestriction

McClellan Sees Roadblocks To Passing Biogenerics Bill This Year

Executive Summary

Former FDA and CMS chief Mark McClellan sees a number of potential roadblocks to passing generic biologics legislation in 2007

You may also be interested in...



PDUFA Draft Bill Adds $70 Mil. For Rx Safety To User Fee Totals; Mark-Up Looms

A draft of the bill to reauthorize FDA's user fee program would add $70 million to the total fee negotiated by the agency and industry in order to pay for additional Rx safety oversight

PDUFA Draft Bill Adds $70 Mil. For Rx Safety To User Fee Totals; Mark-Up Looms

A draft of the bill to reauthorize FDA's user fee program would add $70 million to the total fee negotiated by the agency and industry in order to pay for additional Rx safety oversight

Scientific, Not Legal, Developments Are Key To Generic Biologics – McClellan

Generic drug firms can speed creation of a pathway for generic biologics by focusing on the science behind the products, former FDA commissioner Mark McClellan said

UsernamePublicRestriction

Register

LL035386

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