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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

US Proposed ACNU Rule Rings Bell About Rx Drugs Marketed After NDAs Eliminated With OTC Switches

Proposal for simultaneous Rx and OTC sales of same drug at same dose and indication has CHPA hoping FDA acknowledges Pataday and Voltaren Arthritis Relief are competing with Rx equivalents even though elimination of prescription NDAs was part of approvals for the two switches.

FDA Prescription To OTC Switch

Will ACNU Proposal’s Dual Rx/OTC Component Simultaneously Help And Hinder Switches?

Proposal is counter to fundamental of FDA platform for approving drugs as either Rx or OTC, with a formulation of a drug with a certain indication available in one class, not both. CHPA says the proposal also runs counter to encouraging pharma firms to invest in research needed for OTC switches.

USANA Looks Inside US, Outside Nutrition Sector For Growth Drivers, Acquiring Oolah, Rise Bar

USANA also signals its turning outside nutritional products sector for potential growth driver. One of two firms it’s acquiring, Oola Life Inc., also provides life coach services directly to customers as well as nutritional supplements.

Dietary Supplements M & A

In Comments And In Person, Pharmacist Groups Remind US FDA They'll Provide ACNU Help

Pharmacist groups’ representatives, in meeting with FDA officials, reiterate argument for greater role in access to OTCs through “additional conditions for nonprescription use.” Group not at meeting, American Society of Health-System Pharmacists, suggests “intermediate approach to nonprescription status.”

Prescription To OTC Switch FDA

‘Fail First’ Requirement In ACNU Proposal Prompts Adverse Reactions Across US Drug Industry

PhRMA captures tone of its comments saying “proposed rule might play an important role” in making more drugs available OTC. AAM also references gauntlet, saying proposed pathway “would, in theory, broaden the types of nonprescription drugs available to consumers.” CHPA discusses same concerns as well as additional questions for FDA.

Prescription To OTC Switch FDA

Approved Nearly 75 Years Ago, Bufferin NDA On Withdrawal Notice Due To Registration Lapse

Attention must be paid when withdrawal is for NDA approved in 1948 for brand synonymous with nonprescription pain relief, Bufferin. Even when FDA’s decision amounts to NDA database recordkeeping, withdrawal of application demands notice in US OTC space.

OTC Drugs Drug Approval Standards
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