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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

US FDA Supplement Facility Inspection Numbers Back To Typical Along With GMP Problems Found

Supplement facility GMP inspections by FDA in 2022 along with the frequency of form 483s sent to firms following inspections return to roughly pre-pandemic annual numbers after dipping during 2020 and 2021.

Dietary Supplements FDA

US OTC Monograph Drug Facility Fees Up 8%, Higher Price Tags Stuck On OMORs, Too

FY2023 OTC monograph user fee target facility fee revenue is $25.4m from manufacturers’ fees of $26,153 and contract manufacturers’ fees of $17,435, all due by 1 June. OMOR fees are $517,381 for Tier 1 requests and $103,476 for Tier 2.

User Fees OTC Drugs

US FDA’s Infant Formula Regulatory Authority Doesn’t Reach ‘All That Needs To Be Fixed’

“This system is fundamentally prone to supply chain disruptions with so few manufacturers,” says Mark Moorman, FDA Office of Food Safety director. In FDLI presentation, he acknowledges delicate balance in stemming distribution of potentially contaminated power formula while sustaining supply.

Consumer FDA

Errors Coughed Up For Dextromethorphan, Guaifenesin In US FDA Electronic Registrations

Three of seven businesses warned since February 2022 about noncompliance with FDA drug reporting requirements have been marketers of OTC cough/cold/congestion formulations made with dextromethorphan or guaifenesin.

FDA OTC Drugs

US FDA Postpones Advisory Panel Meeting On Oral Phenylephrine GRASE

Change noted without elaboration in update to FDA announcement on Nonprescription Drugs Advisory Committee meeting. CHPA also notes change, saying it’s best for Industry and for consumers.

Advisory Committees FDA

Empowered By Evidence Debuts Lists Of Natural Health Ingredients Meeting Its Standards

Global nonprofit supporting evidence-based product development in natural health sector and American Botanical Council announce database intended to help consumers, researchers and health care professionals make natural product choices based on specific scientific and clinical evidence.

Dietary Supplements Research & Development
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