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Malcolm Spicer

US Consumer Health Managing Editor

Washington, DC
Malcolm has expertly covered the OTC drug and nutritional supplement industries and markets since 2006. He provides authoritative and highly analytical insight into how and why the US Food and Drug Administration regulates OTC drugs, including homeopathics, and nutritional supplement manufacturing and marketing and also how companies competing in these industries can most efficiently and effectively comply with FDA regulations, the cornerstone for their success.

Latest From Malcolm Spicer

CV Sciences Makes Move For Increased Softgel Capacity, Captek Launches Gummy Production

CV Sciences closes purchase of Elevated Softgels, a manufacturer of encapsulated softgels and tinctures for the supplement and nutrition industry. Captek Softgel starts gummy supplement production at a 60,000-square foot facility.

Manufacturing Dietary Supplements

Marketplace Shows Consumers Bouncing Off Gummy Form Vitamins, Church & Dwight Sees

More than a decade after acquiring vitafusion and L’il Critter gummy vitamin brands and touting gummy as a key growth driver in the VMS space, C&D’s seeing different market trends.

Dietary Supplements Retail

Naloxone Firms Commit To Boost Capacities In White House Opioid Overdose Epidemic Meeting

Emergent BioSolutions, Harm Reduction Therapetuics, Hikma, Teva and other drug manufacturers commit to increased supply of naloxone and nalmefene in meeting with ]White House Office of National Drug Control.

Prescription To OTC Switch Politics

US Revamped OTC Monograph Program Changes Start With Acetaminophen Skin Reaction Warning

Proposed change is “the first FDA-initiated proposed order that was not statutorily required” by the 2020 legislation authorizing the agency’s overhaul of the program which makes the large majority of nonprescription drugs available in the US.

OTC Drugs Drug Approval Standards

NDAC Among US FDA Advisory Committees With Slot Open For Voting Consumer Representative

FDA asks for nominations for voting or non-voting consumer members of its advisory committees. Also wants to hear from consumer organizations interested in participating in selecting consumer representatives for its advisory committees or panels.

Advisory Committees Prescription To OTC Switch

Clear Eyes Production Problems Prestige Consumer Didn’t See Coming Leave Supply On Shelves ‘Spotty’

“Clear Eyes is a perfect example where we're dual-sourced and two facilities don't usually go down at the same time. This was just a quite an anomaly,” says CFO Christine Sacco, noting PCH works with more than 100 contract manufacturers.

OTC Drugs Supply Chain
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