FDA’s OTC Monograph Division Head Recognizes Need To Speed Process
This article was originally published in The Rose Sheet
Executive Summary
Addressing industry stakeholders as a member of a CHPA conference panel, FDA’s OTC monograph division chief Scott Furness says the agency shares companies’ frustration with the sluggish pace of monograph finalization. However, he shares some good news on time and extent applications.
You may also be interested in...
U.S. Sunscreen Group Suggests User Fees To Expedite Ingredient Reviews
The Public Access to SunScreens Coalition will recommend a user-fee program to improve FDA’s work on TEAs for OTC ingredients. “Despite a number of OTC applications waiting for approval for several years, FDA has not completed the review of applications for any new sunscreen components,” PASS says.
OTC Firms Should Improve Monograph Compliance, Registration – CDER
CDER recommends the OTC industry ensure product innovations comply with monographs or have FDA approval prior to marketing. Umbrella-branding and facility registration rank high for the drug center in 2013.
NaZura’s Lovidia Weight-Loss Supplement Strategy Focused On Brand Building
NaZura BioHealth, spun out from Elcelyx Therapeutics, will market its Lovidia weight-loss product in 2014 when it launches into the direct-response channel, before potential suitors get serious about acquiring the brand.