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Wider Options In FDA's NRT Clinical Trial Guidance, Approval Path Still Narrow

 
• By Malcolm Spicer

FDA's NRT clinical draft guidance is latest piece of its evolving strategy for making available more products to help smokers quit. But FDA maintains requirements that keep approval bar high and its separate draft guidance published in 2018 on nonclinical trials put NRT progress on hold, says Saul Shiffman, an OTC switch consultant with work includes multiple NRT proposals.

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An FDA draft guidance clears up details on clinical trials for smoking cessation or related indications, but the agency still leaves plenty of doubt over whether proposals for novel nicotine replacement therapy products, primarily electric nicotine delivery systems, could be approved.

OTC switch consultant Saul Shiffman, whose work includes multiple NRT projects, describes the clinical draft guidance as the latest piece...

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Pharma Deutschland Seeks To Enter Urban Wastewater Legal Dispute

 
• By David Ridley

The Urban Wastewater Treatment Directive “in its current form, is at an end,” insists Pharma Deutschland CEO Jörg Wieczorek. To put the directive to bed once and for all, the association has applied for leave to intervene in the ongoing EU legal battle in its own right.

Cloudy Tariff Conditions Expected To Linger In US

 
• By Malcolm Spicer

White House announces president extends deadline he set in April for other countries to make new tariff deals from July 9 to Aug. 1, when the administration will start sending letters warning other countries that higher tariffs could take effect.

FDA Takes World Tour In Recent OTC Warnings

 
• By Malcolm Spicer

FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

More from Policy & Regulation

Over The Counter: How To Balance Access And Equity In Self-Care, With Bayer’s Emese Csoke

HBW Insight speaks to Bayer Consumer Health's global strategy director for regulatory, medical, safety, quality, and compliance Emese Csoke about how least how widening access to self-care solutions can be balanced with equity with regards to affordability.

US FDA’s Tough Talk On Talc: Regulating In An Echo Chamber

 
• By Michael McCaughan

An FDA “expert roundtable” on talc produced a new talking point on a potential drug safety risk, but the basis of that claim is difficult to determine.

Paying User Fees Not A Priority For Many OTC Monograph Drug Firms, First Arrears List Shows

 
• By Malcolm Spicer

The 1,383 entries on OMUFA arrears list for facility registrations from FY2021 through FY2025 on FDA’s list exceeds its estimate of 1,134 entities subject to the fee for FY2025.