US-Canada Pilot Could Help FDA's OTC Monograph Update Fly
This article was originally published in The Tan Sheet
HHS' latest semi-annual regulatory agenda lists a US-Canada Regulatory Cooperation Council pilot program as the source of a proposed rule to add the common cold indication for monograph OTC antihistamine ingredients that FDA plans to introduce in March 2016.
You may also be interested in...
Final rule amends FDA regulation on gluten-free labeling to provide alternative means for the agency to verify compliance. It will determine whether a firm is compliant from records it must maintain, and make available for inspection and copying, of the fermented or hydrolyzed supplements and food products bearing the claim.
In a proposed rule, FDA describes to a new audience its long-established policy on drugs and devices marketed for off-label indications. The agency says “some ambiguity surrounds the circumstances” that determine whether a product is regulated as tobacco or as a drug, device or combination product
FTC says Pure Green Coffee perks false claims; NBTY shareholder settles insider trading case; scientific citations trigger warning letter; supplement labels must detail plant source; scientific citations trigger warning; and more news In Brief.