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Medical Devices Extrapolation

Hogan Lovells

The EMA publishes a reflection paper on the use of extrapolation in the development of medicinal products for paediatrics

Hogan Lovells on

The European Medicines Agency (EMA) has published a reflection paper regarding the use of extrapolation when developing medicinal products for paediatric use. ...more

Patterson Belknap Webb & Tyler LLP

Part I: Stakeholder Comments on FDA’s Interchangeability Guidance for Biosimilars

The comment period for FDA’s draft guidance Considerations in Demonstrating Interchangeability With a Reference Product closed on Friday, May 19, 2017. Innovators, biosimilar makers, patients, healthcare providers and other...more

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