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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

Dietary Ingredient Studies For Health Benefits Could Be Fenced In By US FDA IND Proposal

Proposed rule introduces two exemptions agency would allow from needing IND clearance for clinical investigations to evaluate food, supplements or cosmetics. Both begin with basic requirement of trial not intended to support drug development plan or labeling change that would make a food, dietary ingredient or cosmetic an unlawfully marketed drug.

Dietary Supplements FDA

No Change To US FDA’s Risk-Based Homeopathic Enforcement From Its OTC Monograph Overhaul

Final guidance presents same descriptions of six "categories of homeopathic drug products ... potentially posing higher risks to public health” agency stated in 2019 revised draft. Agency adds reference to monograph reform in explanation of how homeopathics aren't GRASE.  

FDA Guidance Documents

US VMS Industry Makes Lame Duck Session List, Checks It Twice For MPL Language

AHPA urges chairs and ranking members of Senate HELP and House Energy and Commerce committees not to pass mandatory product listing legislation or make other changes to FDA regulation of industry before the 117th Congress ends. NPA board members lobby lawmakers about the topic.

Dietary Supplements Politics

Rx Naloxone Marketer's OTC Switch Proposal For Nasal Spray Gets Priority Review From FDA

Emergent BioSolutions’ announcement of FDA accepting sNDA for an OTC 4-mg naloxone nasal spray marks another recent step in agency’s response under Commissioner Califf to Capitol Hill pressure to expand availability of topioid antagonist to help curb opioid overdose death epidemic.

FDA Prescription To OTC Switch

Symptoms Change But Savings OTC Drugs Deliver For US Health Care Spending Continue Growing

Substantially more consumers in 2022 report sleep issues, allergies and skin problems than in 2018 while using quit smoking aids has dropped, according to CHPA’s latest “Value of OTC Medicines” survey. Average annual household spending on OTCs is $645.

Consumer OTC Drugs

US FDA, Industry Prepare For Potential Spread Of Surging Demand For Children’s Pain Relief OTCs

FDA “understands that manufacturers expect availability to continue to increase in the near future.” CHPA is working with members “focused on safeguarding the US supply by maximizing capacity to produce and direct product to where it is needed most.”

Supply Chain OTC Drugs
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