FDA OTC Switch Guidance Omits Some Turns As Approval Roadmap, CHPA Says
In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow. CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.
You may also be interested in...
In this first installment of an exclusive three-part series, global switch expert Dr Natalie Gauld speaks to HBW Insight about what makes a country an attractive environment for switching and highlights those markets leading the way today.
Sponsors can point consumers to video displays, website information and mobile apps to help them choose products that have been switched from Rx to OTC. Draft guidance on innovative switch applications to be followed by rule-making in near future.
Target date moved from August 2018 to February 2019 for publishing an NPRM for allowing currently Rx drug ingredients to be available nonprescription under conditions of safe use. US HHS annual spring update on regulatory priorities for FDA and its other agencies also pushes back target dates for other OTC drug NPRMs, including FDA's long-delayed finalization of several monographs including sunscreen ingredients.