HBW Insight 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

Non-Monograph Drugs Interim Marketing Preservation Urged By CHPA

This article was originally published in The Rose Sheet

Executive Summary

FDA's proposed rule on "material time, material extent" criteria for inclusion of drug conditions in the OTC review would "effectively terminate" the monograph process, CHPA maintains in a March 22 letter to the agency.

You may also be interested in...



Marketing Dosage Units "Difficult" To Determine For Certain OTCs - H&R

Foreign marketing data for classes of OTC drugs without specific dosage instructions should be based on annual sales of the active ingredient rather than the finished product, raw material supplier Haarmann & Reimer states in March 21 comments on FDA's "material time, material extent" proposed rule.

Marketing Dosage Units "Difficult" To Determine For Certain OTCs - H&R

Foreign marketing data for classes of OTC drugs without specific dosage instructions should be based on annual sales of the active ingredient rather than the finished product, raw material supplier Haarmann & Reimer states in March 21 comments on FDA's "material time, material extent" proposed rule.

Pfizer Rid Mousse Pediculicide Approved Under "NDA Deviation"

FDA approved an "NDA Deviation" (21-043) for Pfizer's Maximum Strength Rid Mousse aerosolized foam lice treatment March 7.
UsernamePublicRestriction

Register

RS007823

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