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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

Resolving US Hemp Dilemma Takes Detour As House Starts Farm Bill Re-Authorization Journey

Where a US hemp product firm stands on whether de-scheduling the botanical as a controlled substance in the 2018 farm bill left a loophole allowing chemically derived and potentially intoxicating cannabinoid strains to qualify could determine whether it agrees with the detour.

Cannabidiol CBD Legislation

Seed Health Emphasizes ‘First’ Clinical Validation With VS-01 Vaginal Synbiotic Launch

VS-01 formulated with three proprietary L. crispatus strains – LUCA103, 011 and 009 – identified from more than 600 candidate probiotic strains for superior efficacy in maintaining regulated pH and promoting stability in vaginal health.

Women's Health Dietary Supplements

US Wellness Market People News: MET-Rx/Cena, Plexus/Drabik, Viome/Dorsett, Certified/Morgan

Change at Certified Group testing/regulatory consultancy helm; Plexus Worldwide adds corporate affairs lead; Cena flexes muscles and comedy for MET-Rx; and Viome emphasizes consumer-facing business growth.

Dietary Supplements Executive Changes

Valisure Puts FDA Under Microscope In Complaint On Ranitidine Tests Seeking Damages From GSK

Amended complaint filed 21 May after US Attorney General in March said the federal and state governments, named as co-plaintiffs, wouldn’t intervene and the court ordered the complaint unsealed. Complaint, initially filed in 2019, is critical of FDA, generally alleging agency failed to conduct sufficient oversight and evaluation of GSK’s testing data for ranitidine.

Litigation OTC Drugs

House Draft Farm Bill Narrows Hemp Definition While Industry Juggles States' THC Levels

Ag committee members in 23 May markup likely to broach topic of delta-9 THC limit for hemp. Since hemp was de-scheduled in 2018, cannabinoids other than delta-9 but with psychoactive effects have become leading sales drivers. “Most states now have legal marijuana programs, they just don't know it,” says cannabis industry attorney.

Cannabidiol CBD Legislation

Delivery Device Developer Pushes FDA For Better Weight-Based Dosing For Children’s Acetaminophen

Michael Creaturo’s petition isn’t the first suggestion made to FDA and industry that there’s room for improvement in labeling for children’s doses of some OTC formulations. Creaturo's petition comes after he received a US patent in December 2022 for an “integrated container and dosing device for liquid medication delivery.” 

OTC Drugs FDA
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