Cold Indication For Antihistamines Targeted In Regulatory Agenda
This article was originally published in The Tan Sheet
Executive Summary
The latest regulatory agenda says FDA targets issuing proposed rules on OTC antimicrobial hand wash products in February and leave-on antiseptics in July, and in February to finalize an OTC monograph for oral bronchodilator in combination with expectorants or oral nasal decongestants.
You may also be interested in...
Pediatric OTC Cough/Cold Rulemaking Absent From FDA Regulatory Agenda
The Spring 2015 unified agenda lists June for a final rule on deeming electronic cigarettes and other alternatives to traditional cigarettes and smokeless tobacco products subject to FDA regulation. FDA adds an item to create a single set of regulations on fixed-combination Rx and OTC drugs.
Pediatric OTC Cough/Cold Rulemaking Absent From FDA Regulatory Agenda
The Spring 2015 unified agenda lists June for a final rule on deeming electronic cigarettes and other alternatives to traditional cigarettes and smokeless tobacco products subject to FDA regulation. FDA adds an item to create a single set of regulations on fixed-combination Rx and OTC drugs.
Ambitious Schedule For OTC Monograph Updates On FDA Unified Agenda
Nearly two-thirds of FDA’s planned regulatory actions for the consumer health segment would update the OTC drug monograph, including changes to pediatric cough/cold labeling, acetaminophen dosing, oral care products with benzocaine and labeling for some laxatives.