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

Astringent regulation

This article was originally published in The Tan Sheet

Executive Summary

Final rule revising astringent drug products labeling, making small packaging exemptions consistent with OTC skin protectant drug products final rule became effective Oct. 27. The direct final rule amends regulation by establishing conditions under which OTC skin protectant astringent drug products are generally recognized as safe and effective and not misbranded. FDA published rule in June 13 Federal Register (1"The Tan Sheet" June 16, 2003, p. 10)...

You may also be interested in...



Astringent direct final rule

FDA will allow small package labeling provisions for aluminum sulfate marketed as a styptic pencil due to "extremely low risk" in consumer use situations; modifications are based on those for OTC lip protectant/lip balm drug products, according to Skin Protectant Astringents 1direct final rule. Published in June 13 Federal Register, rule will revise labeling for active ingredient aluminum acetate to be in line with shorter versions allowed for colloidal oatmeal, sodium bicarbonate. FDA published direct final rule along with 2proposed version; both invite public input by Aug. 25. If no opposing comments are received, FDA will publish a confirmation notice that final rule will become effective in 135 days. Astringents are covered under Skin Protectant Final Monograph published June 4 (3"The Tan Sheet" June 9, 2003, p. 6)...

EU IVDR: Bisazza Explains Why Regulators Must Act Now To Defuse “Ticking Timebomb”

Industry’s message may continue in a similar vein, but the urgency over the implementation of the EU IVDR has grown to a point where it is desperate for some solution to what it sees as an impending disaster for IVDs in the EU.

Slump In Generic Submissions Helps US FDA Draw Nearly Even With Approvals

ANDA approval rates have remained steady, while submission rates dropped compared to prior years.

Topics

UsernamePublicRestriction

Register

PS096104

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