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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

US House Appropriators Request CBD Enforcement As They Ante Up $5M For FDA's Rule Development

Appropriation Committee members target $5m for FDA's CBD policy work and suggest the agency enforce against noncompliant firms in their report accompanying legislation proposing the agency’s fiscal 2021 budget. 

Cannabidiol CBD Dietary Supplements

New Report, Same Theme On US FDA's Policy On Cannabidiols: ‘Extensive Data Gaps’ On Safety

FDA’s second report to Congress on oversight of CBD market includes results from studies of whether products are mislabeled or adulterated, but also indicates throughout that more data are needed on safety of hemp-derived CBD ingredients used in myriad consumer health, cosmetic and food products already available.

Dietary Supplements Cannabidiol CBD

OTC Loperamide Cardiovascular Label Warnings In US Spread To Perrigo Products

FDA approval for Perrigo's ANDA for two loperamide products listed as tablets follows CBE label changes Johnson & Johnson and BionPharma made for their branded OTCs containing the ingredient in 2019.

OTC Drugs Drug Approval Standards

US OTC Decisions In June: Third Tentative Approval For Omeprazole Delayed Release ANDA, More Esomeprazole PPI Final Approvals

FDA told P&L Development, as it had with Aurobindo Pharma and Hetero Drugs, that its ANDA for a generic of Prilosec OTC delayed release is tentatively approved because exclusivity has not expired for Perrigo's first-approved generic of the PPI.

Drug Approval Standards OTC Drugs

US House Appropriators Keep A Bullseye On FDA’s CBD Regulation Development

Appropriations subcommittee notes the funding in summary of its draft budget bill. Language on FDA’s development of CBD regulatory framework will be included in panel’s report to be released 24 hours before full committee’s markup.

Cannabidiol CBD Legislation

Methanol-Contaminated Sanitizers Stain Production Flexibility Spurred By Pandemic In US

In update to notifications about hand sanitizer labeled as containing ethyl alcohol but contaminated with methanol, FDA says some distributors are voluntarily recalling products. But manufacturer Eskbiochem didn't respond to request to recall its products marketed in US under multiple brands.

OTC Drugs FDA
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