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Condom Approved In US With Anal Sex Indication Through FDA Process Encouraging More Proposals

 
• By Malcolm Spicer

With approval, FDA created regulatory classification allowing subsequent devices of same type with same intended use may go through 510(k) pathway, allowing devices to obtain clearance by demonstrating substantial equivalence to a predicate device.

• Source: Alamy

A condom with labeling to help reduce transmission of sexually transmitted infections during anal intercourse has been approved for the first time in the US through a regulatory pathway likely to spur additional proposals for additional condoms to have the indication.

The Food and Drug Administration has authorized Global Protection Corp.’s One brand natural rubber latex condom to use the labeling,...

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AESGP Annual Meeting: Wastewater Directive Impact Assessment ‘Fundamentally Flawed’

 
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AESGP president Jonathan Workman opens the 61st Annual Meeting with calls for industry unity in the face of the problematic revised EU Urban Wastewater Treatment Directive.

More from Policy & Regulation

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

FDA Proposes Requiring Unit-Dose Packaging For Orally Disintegrating OTC Monograph Drugs

 
• By Malcolm Spicer

Marking most strident use of authorities it received in 2020 as part of an overhaul of monograph system, FDA publishes proposal to shift orally disintegrating formats to individual-dose packaging and a related proposal to minimize firms’ regulatory burden for making delivery format changes potential

Senators’ Questions Stray Far From OMUFA During HELP Committee Hearing On Reauthorization

 
• By Malcolm Spicer

HELP members state frustration with layoffs at FDA and pose questions about topics from generic drug approvals to OTC switches, and from manufacturing location labeling to whether the federal agencies intrude on US consumers. Still, acting CDER director Jacqueline Corrigan-Curay makes clear the resu