FDA publishes discussion paper and seeks public input on 3D printing of medical devices at the point of care

10 December 2021 - Today, the U.S. FDA published a discussion paper regarding 3D printing medical devices at the point of ...

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Patient advocacy organisations and FDA drug approval: lessons from Aduhelm

23 July 2021 - In the wake of last month’s controversial FDA approval of Biogen’s Aduhelm, Alzheimer’s Association CEO Harry ...

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The FDA announces Patient Engagement Advisory Committee meeting on utilising real world data from patient-driven platforms that connect and empower patients

21 September 2018 - On 15 November 2018, the FDA’s Patient Engagement Advisory Committee will hold its second public meeting ...

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Statement from FDA Commissioner on new agency efforts to advance the patient voice in medical product development and FDA regulatory decision-making

12 June 2018 - Over the past decade, advances in our understanding of the basic biology of serious and life-threatening ...

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FDA drafts new guidance on formal meetings between FDA, biosimilar sponsors

4 June 2018 - The US FDA has released new draft guidance on formal meetings between biosimilar sponsors and the ...

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Clinical trial participants should have a say in new drug pricing

18 May 2017 - People who volunteer to participate in clinical trials of new drugs provide a valuable service to ...

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