News & Analysis as of

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complete response letters (CRLs) for BLA and NDA products not yet approved – including CRLs associated with pending or withdrawn applications.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

Goodwin

California’s AB 2013: Generative AI Developers Must Show Their Data

Goodwin on

California Assembly Bill 2013 (AB 2013), known as the Generative Artificial Intelligence: Training Data Transparency Act, was signed into law on September 28, 2024, and is set to take effect on January 1, 2026. ...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

Skadden, Arps, Slate, Meagher & Flom LLP

SEC Staff Issues Disclosure Guidance on International Intellectual Property and Technology Risks

Skadden, Arps, Slate, Meagher & Flom LLP on

In December 2019, the Division of Corporation Finance (Staff) of the U.S. Securities and Exchange Commission (SEC) published new "CF Disclosure Guidance: Topic No. 8" (Guidance) regarding disclosure obligations companies...more

4 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide