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Trade Secrets Regulatory Requirements Pharmaceutical Industry

A Trade Secret is any information, not generally known or easily ascertainable, by which an enterprise develops an economic advantage over competitors or customers. In order to maintain trade secrets'... more +
A Trade Secret is any information, not generally known or easily ascertainable, by which an enterprise develops an economic advantage over competitors or customers. In order to maintain trade secrets' protected legal status, enterprises must make reasonable efforts to keep the information secret and prevent unnecessary disclosure.  Trade Secrets may include processes, formulas, methods, designs, patterns, et cetera.   less -
Hogan Lovells

FDA releasing Complete Response Letters for drugs and biologics that have not yet been approved

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) is now releasing complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications. ...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Foley & Lardner LLP

AI in Drug Discovery: 2025 Outlook

Foley & Lardner LLP on

Looking forward to the 2025 prediction season, a survey of the emerging AI-powered drug discovery landscape has been making the rounds—and with good reason. The survey, summarized by Stanford’s Chris Bradbury, is likely the...more

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