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OTC Monograph Reform Proposal Offers Two-Tier Approach

 
• By Malcolm Spicer

One tier could provide two-year exclusivity, should FDA request clinical trials for new conditions or ingredients, under a US Senate discussion draft. Essentially stalled monograph process would be replaced by deadlines for FDA action in under two years.

FDA approved background, 3D rendering, blue street sign

Industry could have two tracks for proposing changes to OTC products marketed under the US monograph system: one for adding new medical conditions treated by the ingredients, which would be eligible for exclusivity when clinical trials are required, and another for most other types of changes.

The approach is proposed in a discussion draft of legislation to create a user fee program for OTC products, authored by Sens. Johnny Isakson and Bob Casey. The...

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More from Policy & Regulation

Supplementation Unlikely To Help With Hereditary Hair Loss, Says German Agency

 
• By David Ridley

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NAD Asks FTC To Pull Bandage Off Firm’s Plan To Exhaust Inventory Using ‘2X Faster Healing’ Claim

 
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• By Malcolm Spicer

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