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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.
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Latest From Malcolm Spicer

Senate FDA Appropriation Includes $2M For CBD Enforcement Discretion Policy

Instruction in Appropriations Committee report on FY 2020 spending bill garners support from some stakeholders while others say setting a safe level of CBD's use in non-drug products should come first. Senate appropriators endorses FDA policy that regulations allowing sales of CBD non-drug products "not discourage the development of new drugs."
Dietary Supplements Legislation

Less Success 'Expected' In 'OTC Setting' Trial For GSK's NRT, Expert Tells NDAC

While lower than  results in GSK standard efficacy trial, 'real world' success still is clinically significant, firm's experts tell FDA advisory committee after agency officials asked the panel to consider whether the results translate to clinically meaningful benefit for GSK's proposed mouth spray NRT.

United States Health

NDAC Recommendation To Approve GSK's Mouth Spray NRT Comes With Caveats

No more than three votes decided the panel's recommendation on each FDA question, and members in the prevailing majorities explained they made their votes with reservations. Potential use by young consumers and confusion by adult users in following the label instructions were primary concerns for all panel members.

International United States

With Novel NRT Proposal, GSK Includes Novel Labeling: 'Quick Start Guide'

Results of both its clinical trials showed significantly higher rates of smoking abstinence, but GSK adds first labeling for an NRT formatted as a Quick Start Guide and makese other label changes "to further assist consumers in how to use the spray dispenser." Similarity of mouth spray formulation's safety profile to other OTC NRTs is a key point in GSK's proposal.

OTC Drugs Advisory Committees

'Naturalistic' Trial In GSK's Nicotine Mouth Spray NDA Historic For OTC NRTs

What FDA describes as "real world" trial was "designed to include a broader patient population and without providing any verbal behavioral support," says GSK. "Historically, the FDA has not required OTC NRTs to demonstrate efficacy in naturalistic conditions," it says.

OTC Drugs FDA

GSK Proposal For Novel Delivery NRT Leaves FDA Doubting 'Real World' Efficacy

In briefing materials NDAC to consider NDA for first mouth spray delivery NRT, agency also questions whether GSK study data show product is safe for OTC access for consumers. DNDP notes the GSK's clinical trial "consistent with a prescription use setting" showed higher success second trial "designed to be consistent with typical OTC use."

OTC Drugs FDA
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