HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


FDA's Final IND Guidance Has Industry On Edge: What Happens Next?

This article was originally published in The Rose Sheet

Executive Summary

It remains to be seen how industry responds to FDA's newly reissued final guidance advising firms to file Investigational New Drug applications for studies exploring would-be cosmetics' structure/function benefits, and how rigorously the agency enforces its position. Attorney Paul Hyman speculates that FDA could rely on INDs to reinforce its authority in the context of warning letters issued to cosmetics firms for unapproved drug claims.

You may also be interested in...

FDA Rulemaking Could Be Imminent On Investigational New Drug Requirements For Cosmetics, Dietary Supplements

Are investigational new drug applications required for clinical trials conducted by cosmetics companies to evaluate potential body structure/function effects, or clinical studies undertaken by dietary supplement companies to support a new or expanded health claim? FDA said they are in final guidance reissued in late 2015 and now has rulemaking planned on the subject that could commence this month.

FDA Warns Pharmagel, Updates Webpage On Drug-Claim Violations

Pharmagel's name and billing as "pharmaceutical grade anti-aging skin care" may have drawn FDA's attention, but benefits cited in the agency's warning letter – including collagen- and elastic-building claims – are consistent with FDA's enforcement action against other companies so far in 2015.

Audio Feature: FDA Monitoring Cosmetic Claims, But Litigation Remains Biggest Threat

Attorney Steven Shapiro, a partner at Ullman, Shapiro & Ullman, LLP, offers perspective on what he considers some of the biggest challenges cosmetics companies face in the current regulatory and legal landscape, specifically when it comes to crafting claims. Story features audio clips from the attorney’s interview with “The Rose Sheet.”

Latest Headlines
See All



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