McNeil Expands Tylenol Recall As FDA Criticizes Firm's Response To AERs

McNeil Consumer Healthcare's reaction to signs of potentially contaminated packaging for OTC products including Tylenol raised FDA's ire and is now costing the firm an extensive product recall

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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.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
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This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

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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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Health Canada Proposes Major Regulatory Overhaul To Combat Drug, Device Shortages

 
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Canada’s health products regulator is inviting feedback on a range of new and revised guidelines and regulatory tools that explain how drug and device companies will be able to comply with significant changes proposed to its shortages framework.

Ozempic & NAION: EU Safety Panel Continues Probe Into Link With Eye Condition

 

The European Medicines Agency says it will take appropriate measures to update the Ozempic’s package leaflet if new evidence arises.

New EU Filings

 

Doxecitine/doxribtimine, UCB’s investigational orphan drug for pediatric and adult patients with thymidine kinase 2 deficiency, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.