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OTC DFL ‘Remains Static, Non-Customizable Tool’ As US FDA Lifts Curtain On Potential Changes

 
• By Malcolm Spicer

Webinar on DFL requirements was a good launch toward potential changes, says CDER Office of Nonprescription Drugs Director Theresa Michele, "This is a great opportunity for us. I think we are on the cusp of a lot of neat things in the OTC marketplace."

In an FDA webinar slide, California State University, Sacramento, marketing researcher Jesse Catlin captured the consensus about OTC DFLs required by the agency. • Source: Jesse Catlin/FDA webinar

Drug Facts labels required for OTC drugs available in the US have been a success but leave a lot of room for improvement, according to a consensus of Food and Drug Administration officials and drug labeling experts.

“Having been in the marketplace for 20 years, the remarkable safety profile of OTC drugs using the DFL format I...

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FDA Takes World Tour In Recent OTC Warnings

 
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FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
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The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
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AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
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More from Policy & Regulation

Haleon Study: Self-Care Policies Could Save Finland €60m Per Year

 
• By David Ridley

Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.

PAGB: UK Gov Must Invest In Self-Care To Realize ‘Untapped Potential’

 
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Reacting to chancellor Rachel Reeves' 2025 public spending review, PAGB welcomed increased funding for healthcare and life sciences while stressing the need to promote self-care practices.

FDA Takes World Tour In Recent OTC Warnings

 
• By Malcolm Spicer

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.