FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure
This article was originally published in The Tan Sheet
Rx-to-OTC switch sponsors should not wait for FDA to act on NSURE before proposing innovative switch solutions, because reviewers are open to discussing ideas now, an agency official says. Some experts predict the new switch paradigm will not yield concrete regulatory changes, and are promoting other ways to expand OTC access.
You may also be interested in...
US Appropriators Question FDA’s OTC Switch Process Overhaul, Homeopathic Market Oversight
Appropriations Committee’s report with Agriculture, Rural Development, FDA and Related Agencies FY2021 budget bill also reiterated concern about adding acetaminophen dosing information for children to OTC monograph. But its mentions of FDA initiative to expand ingredients available OTC and homeopathic market oversight were firsts.
FDA Aims To “NSURE” Clarity About New Paradigm For OTC Switches
FDA official Rikin Mehta assures stakeholders that the proposed new paradigm for Rx-to-OTC switches would not create a third class of drugs, give pharmacists prescribing power or eliminate the need for consumers to visit doctors.
Colgate Bids To Expand U.S. Toothpaste Lineup Through FDA Rulemaking
Colgate seeks regulatory approval for a version of its Colgate Sensitive Multi-Protection toothpaste in a formulation it already markets internationally. The request made in a citizen petition comes after Colgate’s plan to expand its U.S. toothpaste business failed when FDA did not give approval for Sensitive Pro-Relief.