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Making Progress On Novel OTC Switch Rulemaking Has FDA Commissioner Nominee Califf’s Attention

 
• By Malcolm Spicer

Responding to Sen. Roger Marshall’s question on rulemaking to accelerate OTC switches by allowing NDA sponsors to use extra-label information to guide consumers through self-selection of a drug, Robert Califf said he’d support making progress on a proposal FDA began considering in 2012 in its NSURE initiative.

Robert Califf in fornt of FDA building
• Source: FDA images combined

Robert Califf’s likely confirmation by the Senate would send him to the Food and Drug Administration commissioner post with him “mindful” that modernizing the agency’s Rx-to-OTC switch paradigm has been a regulatory goal for a decade.

Califf, who previously was commissioner for 11 months ending in January 2017, answered Health, Education, Labor and Pensions Committee members...

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German Switch Committee Supports OTC Melatonin And Acyclovir, Rejects Rupatadine

 
• By David Ridley

Germany’s Expert Committee for Prescription supports the Rx-to-OTC switches of melatonin and buccal acyclovir but rejects rupatadine.

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• By Tom Gallen

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• By David Ridley

Now available without a prescription, Dymista Control is the first OTC combination treatment for consumers who are struggling to control their seasonal allergic rhinitis with a corticosteroid or antihistamine nasal spray, according to the firm.

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.

More from Health

German Switch Committee Supports OTC Melatonin And Acyclovir, Rejects Rupatadine

 
• By David Ridley

Germany’s Expert Committee for Prescription supports the Rx-to-OTC switches of melatonin and buccal acyclovir but rejects rupatadine.

People On The Move: Appointments at BioGaia, Assosalute, Bayer

 
• By Tom Gallen

A round-up of the latest European people moves: BioGaia hires new subsidiary head from L'Oréal; Assosalute gets new director; Bayer renews contract of CEO.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.