OTC Label Two-Column Format Is "Significant Space Saver" - CHPA

The use of a two-column format in the "Warnings" section of OTC drug labels would allow for more information in the "Drug Facts" section and help solve some of the space problems created by FDA's OTC labeling final rule, the Consumer Healthcare Products Association says in a May 6 letter to the agency.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.

ICH Modernizes Stability Testing Guideline

 
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The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.