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Cloud Over FDA Advisory Panel Meeting From ‘Over-Reporting’ In Birth Control OTC Switch Study

 
• By Malcolm Spicer

While HRA consultant says its study “meets or exceeds standards of most other studies assessing adherence, including an oral contraceptives,” FDA ONPD director says particpants’ over-reporting “is not something we see in a typical actual use study.”

• Source: Shutterstock

The US Food and Drug Administration is holding the line on requiring reliable data supporting an OTC switch application no matter how much and how often the sponsor describes the numerous public health benefits of expanding access to a daily oral contraceptive.

Agency officials, on 9 May during the first day of a two-day advisory panel meeting conducted online, also heard almost...

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EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
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If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

AESGP Annual Meeting: Wastewater Directive Impact Assessment ‘Fundamentally Flawed’

 
• By David Ridley

AESGP president Jonathan Workman opens the 61st Annual Meeting with calls for industry unity in the face of the problematic revised EU Urban Wastewater Treatment Directive.

‘We Must Have The Truth’ – Calls For UWWTD Review Intensify As Evidence Looks ‘Shaky’

 
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The evidence underpinning the “polluter pays” principle of the revised Urban Wastewater Treatment Directive - which calls on Europe's pharmaceutical industry to cough up at least 80% of the cost of updating wastewater treatment facilities - is looking increasingly shaky, according to a new report.

More from Policy & Regulation

AESGP Annual Meeting: Wastewater Directive Impact Assessment ‘Fundamentally Flawed’

 
• By David Ridley

AESGP president Jonathan Workman opens the 61st Annual Meeting with calls for industry unity in the face of the problematic revised EU Urban Wastewater Treatment Directive.

Over The Counter: Driving Innovation In France’s Self-Care Market, With NèreS’ Luc Besançon

 
• By David Ridley

HBW Insight speaks to NèreS' executive director Luc Besançon about the key issues facing France's self-care industry, especially Rx-to-OTC switch and the revised Urban Wastewater Treatment Directive.

FDA Draft Guidance Waves Green Flag On Changing Color Additives For Drugs In US

 
• By Malcolm Spicer

In a nod to drug manufacturers’ potential interest in moving to natural alternatives for petroleum-based synthetic dyes the agency intends to remove from use, document explains process for asking for approval for “any dye, pigment, or other substance that can impart color to a food, drug, cosmetic,