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Trade Secrets Transparency Food and Drug Administration (FDA)

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complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications.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

Sheppard Mullin Richter & Hampton LLP

Trade Secret Protection & the COVID-19 Cure: Observations on Federal Policy-Making & Potential Impact on Biomedical Advances

As the COVID-19 pandemic spreads throughout the United States and Americans anxiously await the arrival of a vaccine, biotech companies are grappling with the uncertainty of patent protection for COVID related biomedical...more

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