21-02-2019

Singapore: EU Parliament gives green light to EU-Singapore trade and investment protection deals

(Source: EU Parliament 2019-02-22)

Parliament endorsed the free trade and investment protection deals between EU and Singapore, serving as blueprint for further cooperation with Southeast Asia.

21-02-2019

US: CBER guidance on gene therapies – what to expect in 2019

(Source: RAPS 2019-02-21)

The US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) on Wednesday released plans for what guidance is to be expected in 2019, including six final guidance documents related to gene therapies.

19-02-2019

US: FDA finalizes guidance on regenerative medicines expedited programs

(Source: RAPS 2019-02-20)

With almost 80 regenerative medicine advanced therapy (RMAT) designation requests in 2017 and 2018, it’s clear that the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) has been busy with RMATs, though only on Friday did the agency finalize guidance from 2017 on the designation.

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