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Regulatory Oversight › Biotechnology › Healthcare

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Arnall Golden Gregory LLP on

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Nelson Mullins Riley & Scarborough LLP

Minimizing the Fallout from Increasing FDA Clinical Holds

Nelson Mullins Riley & Scarborough LLP on

With medical and scientific advances progressing at an exponential pace, FDA appears to be taking a more aggressive stance in imposing clinical holds on studies where adverse events are reported. Over the last several years,...more

Hogan Lovells

EMA warns marketing authorisations holders to notify type I variations earlier

Hogan Lovells on

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

FDA proposes streamlining combination product regulations

Hogan Lovells on

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more

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