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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.
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Latest From Malcolm Spicer

OTC Drug Manufacturer Warned On GMP Problems FDA Initially Found In 2010

"In response to each of those inspections and compliance actions taken against your firm, you proposed specific remediations to fully address the violations," says FDA in warning letter to TG United. Firm in 2013 recalled 44 products – totaling some 688,000 containers plus 2.53m pills or tablets distributed in bulk – due to GMP deviations.
OTC Drugs Regulation

Own-Labeler Let's Talk Health Hears It From FDA About GMPs, Claims

For all but one of nine GMP violations found by FDA officials, warning letter states: "These are repeat violations from the previous inspection of your firm in 2016."
Dietary Supplements FDA

False Documents Land Chinese OTC Firm In Real Regulatory Trouble With US FDA

As HBW Insight reported, following inspection in March, FDA placed Huize Commodity's hand sanitizers, sunscreens and lip balms on import alert in June. During FDA inspection, "multiple documents provided were in fact falsified," according to warning.
OTC Drugs Commercial

Study Takes Measure Of Supplement Size And Link To Swallowing Problems

FDA and CDC Analysis of the 20,791 adverse event reports for vitamins, minerals and supplements from 2006 through 2015 found that 3,962, 19.1%, indicated swallowing problems and the 10 products most commonly identified in the reports all exceeded 17 mm, or 0.67 inch, in length.

Dietary Supplements Safety

NRT Delivery Innovation Proposal In US Doesn't Deliver Expanded Indications

GSK's proposed usage for mouth spray product – reducing withdrawal symptoms, including nicotine craving – differs little from the first NRT product approved in US in 1984. Additional suggested label instructions primarily focus on stating NRTs can be used to reduce smoking or gradually stop tobacco use as opposed to quitting within a specified amount of time.

OTC Drugs Regulation

'Step-By-Step' Label Guidance On Converting Nutrients' Units Of Measure

FDA provides "step-by-step instructions on how to convert" units of measure for folate, niacin and vitamins A, D and E to units required in the agency's 2016 final rule for Supplement and Nutrition Facts labels. Compliance date for firms with sales of $10m and up.

Dietary Supplements Guidance Documents
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