FDA Forced OTC Switch Process Ambiguities Revealed At Subcmte. Hearing

FDA does not have an established procedure in place to prevent the disclosure of protected trade secrets in the event of a forced Rx-to-OTC switch, Center for Drug Evaluation & Research Director Janet Woodcock, MD, told a House panel June 13.

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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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Brazil Pilots Digital Drug Pack Inserts

 

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

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EU Fines Alchem Over Buscopan API Cartel

 
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After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

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A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.