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Freedom of Information Act › Food and Drug Administration (FDA) › Life Sciences

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 -
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

Epstein Becker & Green

Unpacking Averages: Exploring Data on FDA’s Breakthrough Device Program Obtained Through FOIA

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You may be familiar with the data that FDA publicly shares on devices designated as having breakthrough status, and devices ultimately approved after receiving that status....more

Epstein Becker & Green

Unpacking Averages: FDA FOIA Response Times by Topic of Request

Epstein Becker & Green on

Continuing my three-part series on FOIA requests using a database of over 120,000 requests filed with FDA over 10 years (2013-22), this month’s post focuses on sorting the requests by topic and then using those topics to dive...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - September 2022

Latham & Watkins LLP on

Inflation Reduction Act: Stakeholders and commentators continue to review H.R. 5376, the Inflation Reduction Act of 2022 (the Act), which became law on Aug. 16, 2022. Republican leaders on the House Energy & Commerce and...more

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