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Medical Devices Pharmaceutical Industry Marketing Authorization Application

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q3 2023 and Beyond

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As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more

Knobbe Martens

FDA Issues Final Guidance on Transitioning from COVID-19 EUAs

Knobbe Martens on

The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as...more

Latham & Watkins LLP

EU-UK Trade and Cooperation Agreement: Implications for Life Sciences Companies

Latham & Watkins LLP on

The agreement provides guidance across several areas for the life sciences sector, though gaps remain. The widely anticipated EU-UK Trade and Cooperation Agreement (the Agreement) came into effect on 1 January 2021 after...more

Hogan Lovells

COVID-19: Daily Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time....more

Hogan Lovells

Updates on the newest regulatory legislation (Royal Decree 717/2019) in Spain

Hogan Lovells on

On 5 December 2019, the Official State Gazette of Spain published a new regulation passed by the Spanish government which has introduced many significant developments in the Spanish legal framework on medicinal products for...more

WilmerHale

Brexit at Halfway: Pharma and Medical Devices

WilmerHale on

The object of this Alert is to highlight some practical implications of Brexit for the supply of pharmaceutical products and medical devices in the European Union (EU) and related action items which companies should be...more

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