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Trade Secrets Regulatory Oversight Transparency

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complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications.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

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