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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

Five Years In Prison, Nearly $50M Fines For Owner Of US Lab Falsifying Sunscreen Test Results

Garbriel Letizia Jr., and employees at AMA Laboratories “at his direction,” defrauded customers of more than $46m by testing products on materially lower numbers of subjects than specified and paid for by the customers.

Enforcement Cosmetics

US FDA Allows Supplement Firms More Time To Submit NDI Notifications, And For It To Respond

More time for notifications than current deadline of at least 75 days before NDI-containing product is offered for sale in US doesn’t solve problems with FDA’s management of NDI regulation, say trade groups.

Dietary Supplements Guidance Documents

Biden Mandates Prioritizing Supplies For Infant Formula Production Over All Other Uses

Democrats and Republicans vote to approve $28m emergency finding for FDA formula programs proposed in bill introduced day earlier by Democrat leaders on Appropriations Committee. Biden deems Defense Production Act applicable to manufacturing formula products.

FDA Politics

NDI Notification Guidance Deadline Included In Senate Draft Bill For FDA User Fee Programs

HELP Committee Chairwoman Patty Murray, and ranking member Richard Burr also include supplement registration requirement in discussion draft for reauthorizing FDA’s user fee programs for prescription, generic and biosimilar drugs and medical devices.

Dietary Supplements FDA

Preliminary Remediation Begins On Restarting Formula Production At Abbott Nutrition Plant

Decree imposes steps Abbott must complete before it can begin preparing to restart production, including hiring independent consultant to determine whether facility is compliant with FDA manufacturing and labeling regulations.

FDA Enforcement

House Appropriation Leaders Propose Emergency Funding For FDA's Infant Formula Programs

Democrats introduce bill two days before Agriculture, Rural Development, FDA and Related Agencies subcommittee will question FDA Commissioner Robert Califf about agency’s oversight of formula industry during a hearing on FY2023 budget.

FDA Legislation
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