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Malcolm Spicer

Malcolm Spicer, Managing Editor – US

Washington, DC
Malcolm Spicer is lead analyst for Pharma intelligence | informa's coverage of the consumer health care products industries. He provides comprehensive and insightful reporting on manufacturing, marketing, regulation, legislation, financial and research news about the nonprescription drug and nutritional product industries. He has worked in this post for 10 years and previously reported for other publications on regulation of the health care industry, on the telecommunications and internet technologies and on the US energy market.

Latest From Malcolm Spicer

Progress On Adding OTC Drugs To US Market? Room To Move But Label Format Limits Options

Changes for supporting OTC labeling for drugs currently available Rx-only and indicated for chronic, more complicated conditions, aren’t minor and won’t happen within limits of one-dimensional text media printed on OTC drug containers, packages and inserts.

FDA OTC Drugs

‘Heretical’ Rule Changes Could Make More Drugs Available OTC In US – Former NDAC Chair Brass

Harbor-UCLA Center for Clinical Pharmacology director Eric Brass says FDA should change DFL requirements, considering container labels as part of OTC labeling and reconsidering what information should be included on labels and threshold for consumer comprehension of labels.

Drug Approval Standards FDA

UK Vibrating Device Marketer Unshaken By Regulatory Action Against COVID-19 Claims

Psychologist Anthony Grant operates “Resonator.UK” and sells a device that vibrates on the 30kHz frequency at 30,000 times a second. Claims including “the only safe way to destroy a virus is to shake it to pieces” challenged by MHRA and consumers.

Ad Complaints OTC Devices

Colgate Slams Industry Self-Regulation Review But Agrees To Pull Optic White Stain Removal Claim

BBB National Programs’ appeals panel decision “includes factual and substantive inaccuracies, is not in accordance with NARB procedures, and misstates Colgate’s positions and arguments,” Colgate says. Panel upheld findings agreeing with P&G’s challenge of “removes 10 years of yellow stains” claim.

Ad Complaints Commercial

OTC Allergy Switch Approved For Bayer In US

CDER approves Bayer Healthcare’s azelastine 0.15% nasal antihistamine indicated for seasonal and perennial allergic rhinitis in adults and children 6 and older. Bayer says Astepro Allergy is first steroid-free antihistamine for allergies available OTC in the US and the first indicated for indoor and outdoor allergy relief.

Prescription To Otc Switch FDA

US Consumers Don’t Know Where To Start With OTC Drug Fact Labels, Most Look Online For Help

“We created a warning wallpaper, which means it looks like one block of overwhelming warnings,” says drug labeling expert Julie Akers. Technology has changed the world with nonstop access to information on multiple devices from myriad digital sources, but DFLs remain one-dimensional, static media.

FDA Prescription To Otc Switch
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