HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.
Set Alert for Articles By Malcolm Spicer

Latest From Malcolm Spicer

GSK Leaving Pennsylvania Emergen-C Plant, Adding Voltaren To US OTC Line

UK pharma announced that in 2021 it will close its manufacturing facility in Carlisle, PA, where around 260 people are employed making the Emergen-C line. It will move the manufacturing to its Guayama, PR, facility.

Business Strategies Prescription To Otc Switch

Innovo Incontinence Device Goes OTC In US, Labeled To Be Worn For 30 Minutes

Atlantic Therapeutics estimates that one in three women are incontinent, but 60% don’t ask their health care providers about treatment, a statistic that supports offering Innovo OTC less than two years after it launched Rx in the US.
Prescription To Otc Switch Commercial

US OTC Switch Drought Ends: FDA Approves GSK Arthritis Gel, Alcon Allergy Eye Drops

FDA approved sNDAs from GlaxoSmithKline for diclofenac-containing Voltaren Arthritis Pain for the temporary relief of arthritis pain and from Alcon for Pataday olopatadine drops at 0.2% concentration for once-daily use temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander and 0.1% for twice-daily use for the same indications plus redness relief.

OTC Drugs Prescription To Otc Switch

CBD Lotion Firm’s ‘FDA Certified’ Claim For 'OTC Drug' Is Certifiably Noncompliant

In addition to CBD, Elixicure is formulated with OTC external analgesics monograph ingredients camphor and menthol, But CBD isn't a monograph drug nor approved for use in any pharmaceutical product other than GW Pharmaceutical's Epidiolex.

Dietary Supplements OTC Drugs

FDA Budget Request Proposes OTC Monograph User Fees And ‘Field Alerts’

In addition proposing $28.4m in monograph user fees, agency’s FY 2021 budget justification includes among its legislative initiatives proposing to require "Field Alert Reports" for drug products not marketed under an approved application, such as monograph OTCs.

OTC Drugs Legislation

FDA Budget Request Includes $5M For CBD Regulation With Pathway Unclear

FDA includes cannabis product regulation in FY 2021 food safety priorities, “key areas where resources have been historically underfunded and for which there are rising public health needs as growing markets outpace increases to Agency resources,” it states in its budget request.

Dietary Supplements FDA
See All
UsernamePublicRestriction

Register