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Trade Secrets › Life Sciences › Disclosure Requirements

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complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications.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

Ropes & Gray LLP

Protecting Trade Secrets in FDA Submissions from FOIA Disclosure in the Wake of FDA Layoffs

Ropes & Gray LLP on

In the wake of recent mass layoffs at the U.S. Food and Drug Administration (“FDA”), the FDA is likely to have fewer resources to manage its regulatory responsibilities. One area that may be significantly impacted by such...more

J.S. Held

IP and Tech: Twin Engines of Innovative Sustainability

J.S. Held on

In the quest for a sustainable future, the United Nations’ Sustainable Development Goals (SDGs) represent goalposts, albeit lofty ones, that countries can aim for. These 17 interconnected goals address pressing global...more

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