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Regulatory Oversight Pharmaceutical Industry Marketing Authorization Application

Ballard Spahr LLP

FDA Issues Guidance on AI for Medical Devices

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The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more

Hogan Lovells

New drug marketing applications: how do EMA and FDA compare?

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A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more

Hogan Lovells

EMA warns marketing authorisations holders to notify type I variations earlier

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On 26 October 2018, the European Medicines Agency (EMA), advised marketing authorisation holders to submit type I variations prior to the temporary closure of the EMA. The EMA will relocate from London to Amsterdam and will...more

Hogan Lovells

European Commission invites targeted stakeholders for consultation on duplicate marketing authorisations for biological medicinal...

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The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more

Hogan Lovells

New version of EMA’s pre-authorisation procedural advice for the centralised procedure released

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On 4 May 2018, the European Medicines Agency (“EMA”) published another updated version of the guidance document on pre-authorisation for users of the centralised procedure. ...more

Hogan Lovells

EMA released Practical Guidance for Brexit and Market Authorisation Holders

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The European Medicines Agency (“EMA”) has released a Practical Guidance concerning the steps that centralised Market Authorisation Holders (“MAH”) will be required to take should the United Kingdom (“UK”) become a third...more

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