Pink Sheet is part of the Business Intelligence Division 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

FDAMA pediatric research language entitles OTC drugs to exclusivity eligibility -- NDMA.

This article was originally published in The Tan Sheet

Executive Summary

FDAMA LANGUAGE FOR PEDIATRIC RESEARCH LIST WORDED TO INCLUDE OTCs, NDMA argues, and Congress would have excluded over-the- counter drugs specifically if it had so intended, the Nonprescription Drug Manufacturers Association says in May 27 comments to FDA. The comments respond to statements made jointly by the Generic Pharmaceutical Industry Association, the National Association of Pharmaceutical Manufacturers and the National Pharmaceutical Alliance that there is neither legislative intent nor is there language in the FDA Modernization Act allowing for potential extended marketing exclusivity for OTCs if new data are discovered that could benefit the health of the pediatric population ("The Tan Sheet" May 25, p. 12). NDMA says the generic drug alliance comments contain "numerous errors of law and fact."
Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

PS088488

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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