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Disclosure Requirements › Biotechnology › Prescription Drugs

Hogan Lovells

FDA’s creation of public database of 200 Complete Response letters raises questions

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) today published more than 200 complete response letters (CRLs) issued between 2002 and 2024. FDA reports that it has only published CRLs sent to companies whose drug and biological...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Key Inventorship Considerations in AI-assisted Drug Development

Rothwell, Figg, Ernst & Manbeck, P.C. on

The utilization of artificial intelligence (“AI”) is becoming ubiquitous across a wide range of industry sectors. The biotech industry is no exception. AI-driven platforms have become increasingly useful to biotech...more

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