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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

Safe Use Of Hydrogen-Peroxide Contact Lens Solution Magnified in US FDA Draft Guidance

Draft guidance pulls from Ophthalmic Devices Panel and Risk Communication Advisory Committee 2017 meeting to discuss more clearly communicating risks of the solutions to consumers while allowing products to remain available OTC.

FDA Guidance Documents

House Members Object To Senate Adding Supplement MPL Proposal In FDA User Fee Bill

Members led by SC Republican Jeff Duncan and CA Democrat Tony Cárdenas, in letter to House speaker and minority leader, oppose MPL provision in latest version of S.4348 for re-authorizing FDA drug, biologic and medical device user fee programs.

Dietary Supplements FDA

US Proposed OTC Hearing Aid Rule Inspired Soundly Founder To ‘Make This Process Easier’

In recent interview, CEO Blake Cadwell talked about Soundly’s business model and outlook for hearing aid marketplace after FDA's pending publication of rule aiming to make the devices more accessible. Firm since June has offered online testing and advice for customers about hearing aids best suited for their needs.

Mandatory Product Listing: Needed For US VMS Market, Not Mandatory In User Fee Bill – CRN

Establishing VMS products MPL as stated within legislation to re-authorize FDA user fee programs for drugs, biologics and medical device applications isn’t urgent enough to prevent passing user fee bill, says CRN chief Steve Mister.

Dietary Supplements FDA

Misbranding Grades Coming For Compliant VMS Labeling If Found Missing From Proposed MPL

Under Senate legislation proposing mandatory listing with FDA for all supplements sold in US, a product labeled in compliance with all other agency regulations would be deemed misbranded if not registered for  proposed list.

J&J Pulls Plug On Talc Across Its Baby Powder Portfolio, Shifts To Cornstarch-Based Products

As it did when it halted sales in US and Canada in 2020, J&J’s latest announcement attributes its decision as coming from a “portfolio assessment” and stated it remains confident in using talc in baby powder and cosmetics.

Business Strategies Cosmetics
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