OTC Monograph Bill Has Energy And Commerce Date, CDER Director's Hope
Executive Summary
US House is catching up with Senate on OTC monograph legislation, with a committee markup expected in the next few days.
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Rulemaking For OTC Switch Process Changes Pushed To 2019
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.
Rulemaking For OTC Switch Process Changes Pushed To 2019
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.
Senate OTC Monograph Reform Bill Clears HELP For Floor Vote
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