Workshop on evaluating RWE from observational studies in regulatory decision-making

12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on ...

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Developing real-world data and evidence to support regulatory decision-making

26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, ...

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FDA and EMA to hold workshop on breakthrough therapy and PRIME designations

2 August 2018 - The US FDA and EMA will hold a workshop on early access approaches, including PRIME and ...

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FDA sets inaugural meeting of first-ever patient engagement advisory committee

25 July 2017 - Imagine checking your blood sugar levels several times a day with a glucose meter to keep your ...

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PDA/FDA Biosimilars Conference - 26-27 June 2017

3 May 2017 - The FDA and PDA are co-sponsoring a conference to identify best practices for global development and approval ...

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