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Food and Drug Administration (FDA) Life Sciences Research Tools

Goodwin

FDA to Phase Out Animal Testing for Monoclonal Antibodies and other Drugs

Goodwin on

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...more

Fish & Richardson

The Not-So-Safe Harbor for Research Tools: Lessons From the District of Delaware

Fish & Richardson on

In BlueAllele Corp. v. Intellia Therapeutics, Inc., 2024 U.S. Dist. Lexis 222094 (D. Del. Dec. 9, 2024)1, the District of Delaware addressed several issues relevant to the safe harbor defense in Hatch-Waxman litigation. ...more

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