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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

Warnings Note Disease Treatment Studies Placed Too Close To Supplements For US FDA’s Comfort

Dietary ingredients identified in recent FDA warning letters as linked to disease claims by marketers directing customers to scientific literature include omega-3 fatty acid, ginkgo biloba, glucosamine curcumin and vitamin D.

Dietary Supplements Enforcement

OTC Decisions November-December: GSK Labels For Nexium Promotion, Voltaren 2-Pack Approved

Approvals by FDA also include revised container and consumer information labeling for J&J's Men’s Rogaine to align with labeling for Women’s Rogaine;  bonus-pack labeling for Bayer AG’s Aleve; and 

FDA OTC Drugs

J&J CEO: COVID-19 ‘Demonstrated Importance of Self-Care Overall’

During JP Morgan conference, Alex Gorsky suggests responding to pandemic is changing health care, including businesses providing pharmaceuticals, medical technologies, nutritionals and other necessary products.

Business Strategies Coronavirus COVID-19

Hand Sanitizer Problems Prompt US FDA Guidance On Keeping Methanol Out Of Other OTC Drugs

Final guidance, for pharmaceutical alcohol used as an active or inactive ingredient in other drugs as well as hand sanitizers, “will help pharmaceutical manufacturers avoid using pharmaceutical alcohol contaminated with or substituted with methanol in drug products.”

OTC Drugs Guidance Documents

Vaccination Health Next Stop For Dentovations’ Self+ Immunity Supplement Line

Vacci Prep is first “supplement to establish a standard of care for consumers when preparing their immune system for vaccinations,” Dentovations says.

Biotin And ‘Healthy Hair’: Federal Pre-emption Clips False Advertising Complaint In California

US Ninth Circuit affirms a district court’s summary judgment in favor of Target and manufacturer of Up & Up brand biotin supplement it sells. Indian manufacturer targeted in putative class-action in New York prompted FDA’s 2016 creation of import alert category for Ayurvedic supplements.

Legal Issues Consumer
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