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Freedom of Information Act › Regulatory Requirements › Food and Drug Administration (FDA)

The Freedom of Information Act is a United States federal statute enacted in 1966 to promote government transparency and the free exchange of public information. Under FOIA, any individual can request federal... more +
The Freedom of Information Act is a United States federal statute enacted in 1966 to promote government transparency and the free exchange of public information. Under FOIA, any individual can request federal agency records and enforce that right in a court of law. However, not all agency records can be requested; there are nine exempt categories of information. In addition to the federal law, many states have passed their own freedom of information acts. These acts are often similar but not always identical to the federal version.  less -
Offit Kurman

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into...

Offit Kurman on

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...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

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