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FDA's OTC Naloxone Model Labels Confirmed In CONFER Study

 
• By Malcolm Spicer

Participants in FDA-commissioned CONFER study were scored on following label instructions for checking whether a potential patient has overdosed and administering a naloxone dose before calling for emergency help as well as on a "composite of cognitive walkthrough" of all those steps. Participants were in four groups: adult users of heroin and prescription opioids; those persons' friends and family members 18 years old and up; and separate groups of volunteers, 15- to 17-year-olds and adults.

A study of making naloxone available OTC study supports model Drug Fact labels FDA designed even though agency officials noted concern that some participants didn't meet a "clinically critical endpoint" of contacting emergency services immediately after administering the opioid-overdose treatment.

On Jan. 17, FDA published a report on agency staff's review of independent research contractors' study of label comprehension for...

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More from Rx-to-OTC Switch

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.

Navamedic To Market OTC Naloxone In Norway Following Switch

 
• By Tom Gallen

Navamedic adds Ventizolve to its portfolio shortly after Norway switched the opioid overdose reversal drug from Rx to OTC.

Viatris Switches Innovative Dual Action Nasal Spray In The UK

 
• 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.