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Chronic Conditions Data Emphasize Need For Additional, Innovative OTCs

 
• By Malcolm Spicer

An NIH-funded study shows 92% of older consumers have chronic conditions, the primary target of FDA’s Nonprescription Safe Use Regulatory Expansion initiative to facilitate more Rx-to-OTC switches. The agency also extends the comment period for its initiative on making more ingredients available through the OTC monograph process.

National Institutes of Health-backed research and the NIH director’s comments on the prevalence of chronic conditions underscore the significance of FDA initiatives to move Rx drugs to nonprescription, particularly for chronic conditions, and to add ingredients to OTC monographs.

A U.S. Census Bureau report, from research funded by NIH’s National Institute on Aging, shows that 92% of...

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More from Europe

US Tariffs And The EU’s Critical Medicines Act: Lessons On Nearshoring And CMO Diversification

 
• By Francesca Bruce

Nearshoring production and diversifying contract manufacturing networks can help companies stave off cost increases that will be reflected in higher medicine prices.

EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU

 
• By Vibha Sharma

Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

Gilead’s Lenacapavir Up For EMA Verdict Amid Packed CHMP Meeting Agenda

 
• By Vibha Sharma

The European Medicines Agency’s, human medicines committee, the CHMP, is this week poised to issue opinions on potential marketing approvals for 17 products.

Gene Therapy Elevidys Among Six Orphan Drugs Awaiting EU Marketing Verdict

 
• By Vibha Sharma

The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.

More from Geography

EMA Poised To Decide On Fate Of Lilly’s Kisunla And PharmaMar’s Aplidin In EU

 
• By Vibha Sharma

Eli Lilly and PharmaMar were set to make their case before the European Medicines Agency this week as part of re-examination procedures for their respective drugs Kisunla and Aplidin.

After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?

 
• By Derrick Gingery and Mandy Jackson

One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.

Advocates Want New Bipartisan PBM Reform Package To Stand Alone

 
• By Leslie Small

A new PBM reform package has familiar provisions, but stakeholders want it to move as a stand-alone bill, rather than as part of a larger legislative vehicle.