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Freedom of Information Act › Prescription Drugs

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 -
McDermott Will & Schulte

This Week in 340B: February 4 – 10, 2025

McDermott Will & Schulte on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Epstein Becker & Green

Unpacking Averages: Success Rates for FDA FOIAs by Topic and Requester

Epstein Becker & Green on

In prior posts here and here, I analyzed new data obtained from FDA through the Freedom of Information Act about FOIA requests. I looked at response times and then started to dive into the topics that requesters were asking...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

Troutman Pepper

Bass Continues Fishing; Pharma Seeks Sanctuary

Troutman Pepper on

It’s time for an update on Kyle Bass’s efforts to rid America of the pharmaceutical patents that support high priced drugs. Between February and September 2015, at least eleven investment funds organized by J. Kyle Bass and...more

Dorsey & Whitney LLP

Cooperation, the SEC and FOIA

Dorsey & Whitney LLP on

A critical part of cooperating with an SEC or DOJ investigation for FCPA or other possible violations is the production of documents. In order for the company to assess what happened it must conduct an internal investigation...more

Morrison & Foerster LLP

Launch of openFDA Increases Accessibility to Adverse Drug Event Reports

Morrison & Foerster LLP on

On June 2, 2014, the Food and Drug Administration launched openFDA, a program designed to improve access to publicly available data beginning with adverse event reports. While greater accessibility to adverse event reports...more

Patrick Malone & Associates P.C. | DC Injury...

Grand Opening of openFDA.gov

Patrick Malone & Associates P.C. | DC Injury... on

Information is power, and as of this month, there’s a new power source of information about drug effects. openFDA.gov is an initiative of the U.S. Food and Drug Administration to expand access to and use of reports of...more

Mintz

Federal District Court Orders FDA To Produce Records Regarding New Drug Application Pursuant To FOIA

Mintz on

Sponsors of developmental new drugs may want to take additional steps to protect their trade secrets and confidential information in the wake of a recent federal court decision narrowly interpreting certain exemptions to the...more

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