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

Pediatric rule

This article was originally published in The Tan Sheet

Executive Summary

FDA draft guidance on pediatric rule compliance slated for publication in Dec. 4 Federal Register. Published in December 1998, the rule requires that pediatric assessments be included in all NDAs, as well as ANDAs based on suitability petitions for a change in active ingredient, dosage form or route of administration, that are filed after Dec. 2. Although the guidance does not address ANDA suitability petitions, it provides an overview of pediatric assessments, describes waiver/deferral procedures and discusses interactions between the rule and FDAMA pediatric exclusivity requirements
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS091964

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