Podcast: Non-binding Guidance: Expedited Review Programs for Drugs and Biologics
Jones Day Presents: Large Business & International Examination Strategies: Fast Track Settlements
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will analyze whether to rescind a breakthrough therapy...more
The United States Consumer Product Safety Commission (CPSC) recently announced a $5.8 million agreement with Keurig Green Mountain, Inc. settling claims that Keurig failed to report a product defect that posed an unreasonable...more
In This Issue: - Update on Trade Promotion Authority and Companion Trade Bills: A Lot Can Happen In Washington In 34 Days - Congress Allows Export-Import Bank Charter to Expire, for Now - WTO Finds That COOL Is...more
So what is the CPSC’s “fast track recall” program and what is the benefit of participating in it? What is a “stop sale notice” and why does the CPSC generally request it for fast track recalls? What else is required by the...more
The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more