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

House Appropriators Watch Clock On OTC Cough/Cold, Sunscreen Monographs

This article was originally published in The Tan Sheet

Executive Summary

House appropriators recommend FDA in June publish a proposed rule for safety and efficacy of cough/cold OTCs in pediatric populations They also direct FDA by December to complete its review of the remaining sunscreen ingredient safety and effectiveness TEA submissions.

You may also be interested in...



Ambitious Schedule For OTC Monograph Updates On FDA Unified Agenda

Nearly two-thirds of FDA’s planned regulatory actions for the consumer health segment would update the OTC drug monograph, including changes to pediatric cough/cold labeling, acetaminophen dosing, oral care products with benzocaine and labeling for some laxatives.

Ambitious Schedule For OTC Monograph Updates On FDA Unified Agenda

Nearly two-thirds of FDA’s planned regulatory actions for the consumer health segment would update the OTC drug monograph, including changes to pediatric cough/cold labeling, acetaminophen dosing, oral care products with benzocaine and labeling for some laxatives.

House Appropriators Push For Revised Pediatric Cough/Cold Labels

House appropriators want FDA to propose by Dec. 31 revised labeling for OTC pediatric cough and cold products that addresses safety and efficacy concerns.

Related Content

Topics

UsernamePublicRestriction

Register

PS106951

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