FDA seeks to speed approvals of generic drug-device combos

5 December 2017 - New FDA guidance will make it easier for generic companies to get drug-device combination products approved. ...

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First digital pill approved to worries about biomedical ‘Big Brother’

13 November 2017 - For the first time, the FDA has approved a digital pill — a medication embedded with ...

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FDA issues complete response letter for digital medicine new drug application

26 April 2016 - Otsuka and Proteus Digital Health today announced that the US FDA has issued a complete response letter ...

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