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Rx-to-OTC Switch

Set Alert for Rx-To-OTC Switch

Real-World Evidence Can Play Important Role In OTC Regulation – AESGP Study

A published article from AESGP argues for the increased acceptability, application and use of real-world evidence in the OTC sector where it “may present a more intuitive or efficient way of generating data” compared to randomized controlled trials.

Real-World Evidence OTC Drugs

UK Approves Switch Of Higher Dose Calcium And Vitamin D Combination

The MHRA has approved the switch of Consilient Health's Calci-D, which will offer UK consumers the highest dose of vitamin D3 available in combination with calcium as an OTC medicine.

Prescription To OTC Switch OTC Drugs

Who You Gonna Call For US Oral Contraceptive Switch? Former FDA Official Heads Perrigo Americas

Jim Dillard, chief scientific officer for Perrigo since 2019, moves to head the North American business with research and development experience as well as a regulatory background from his work at the FDA.

Leadership Prescription To OTC Switch

Viatris Welcomes ‘Healthy Competition’ For UK OTC Erectile Dysfunction Top Spot

Viatris' marketing director Rob Elliott speaks to HBW Insight about how the company is investing in flagship OTC erectile dysfunction treatment Viagra Connect to ensure the brand keeps ahead of the growing competition. 

United Kingdom Health

‘All The Information’ For OTC Switch DFLs Includes Important Warnings Used On Rx Drug Labels

OTC switches are more challenging for sponsors as concerns over label communication, drug interactions and consumers understanding increase, says FDA official Francis Becker. Rx label precautions and warnings must go on OTC labels, too.


OTC Switch Sponsors’ Flight To Digital Research During Pandemic Could Be One-Way Trip

COVID-19 pushed Rx-to-OTC switch sponsors into digital research to collect data on consumer usage, and many are unlikely to revert to in-person methods, said an OTC switch expert at the Consumer Healthcare Products Association regulatory conference on 9 September.


OTCs' Rapid Remedies Should Mitigate Weight Of Self-Selection Risks For Switches – Consultant

OTC drugs’ quick treatment of acute conditions outweighs risks from absence of physician oversight, says OTC switch consultant Bernie Simone.  At CHPA regulatory conference, he discussed other drug categories during his presentation on the downside of keeping some drug ingredients Rx-only.


Regulation Of US Supplement Industry Needs ‘Really Hard Look’ – FDA's Woodcock

Acting commissioner's comment on supplement industry regulation was her most definitive statement about the agency’s work in consumer health sector at CHPA's regulatory conference. Pandemic, she says, heightened consumer interest in self-care along with demand for OTC drugs and supplements.

Coronavirus COVID-19 Dietary Supplements
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