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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

IND Warning Has US Supplement Firm ISO Answers

RAAS Nutritionals tells FDA “it proceeded without an IND because it believed that if it was legally able to sell its nutritional supplements ... it should be able to test and observe the effects of those supplements without an IND.”

Warning Letters Dietary Supplements

US OTC Monograph FY2022 Facility Fees Deadline In June At Amount TBD

Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.

User Fees OTC Drugs

US FDA Plans Year-End Rinse Of Temporary Policy Easing Standards For OTC Sanitizer Production

FDA makes withdrawal effective on 31 December, also the deadline for firms manufacturing or compounding alcohol-based hand sanitizer products, and making alcohol for those products under temporary guidances, to cease production.

Coronavirus COVID-19 Guidance Documents

OTC Sanitizer Contaminations Drop In US As Auxiliary Manufacturers Stop Production

"Fewer people are manufacturing the products ... That seems to be a sort of a natural reaction to I think the decreased consumer demand," says Donald Ashley, compliance chief in FDA’s drug center.

Coronavirus COVID-19 OTC Drugs

US Petroleum Fracking Firm’s OTC Sanitizer Production Pumps FDA The Wrong Way

One of two US firms among five warned recently about problems with OTC sanitizers is a petroleum product business. Two of the other three warnings went to firms in Mexico, by far the predominant source of adulterated OTC sanitizers found in US since early 2020.

Coronavirus COVID-19 OTC Drugs

US FDA ‘Closer To Zero’ Meeting On Infant Nutrition Safety And Benefits Set For November

CFSAN launched “C2Z” initiative in April following widespread reports of contamination of baby food products. Agency officials will outline C2Z plan including a four-stage approach for continual improvement and additional work related to levels of toxic elements in food.

Pediatrics Dietary Supplements
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