Malcolm Spicer
Malcolm Spicer, Managing Editor – US
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Latest From Malcolm Spicer
OTC Drug Manufacturer Warned On GMP Problems FDA Initially Found In 2010
Own-Labeler Let's Talk Health Hears It From FDA About GMPs, Claims
False Documents Land Chinese OTC Firm In Real Regulatory Trouble With US FDA
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.
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.
'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.