Tag Archives: Unapproved

Joint Action by FDA and FTC Against Companies Marketing Unapproved Opioid Cessation Products

By Riëtte van Laack — On January 24, 2018, FDA and the Federal Trade Commission (FTC) posted joint warning letters to 11 marketers and distributors of opioid cessation products, alleging that those products were unapproved new drugs that violated the … Continue reading

Posted in Products Liability | Tagged , , , , , , , , | Leave a comment

FDA Prevails in 10th Circuit Unapproved Morphine Sulfate Case; Court Does Not Reach Merits of Grandfather Claim

By Kurt R. Karst – In a decision handed down late last week by the U.S. Court of Appeals for the Tenth Circuit, a three-judge panel affirmed a November 2010 decision from the U.S. District Court for the District of … Continue reading

Posted in Products Liability | Tagged , , , , , , , , , , , | Leave a comment

FDA Ramps Up Enforcement on Marketed Unapproved Human Drugs – Revised CPG Says New Products Will be Subject to Immediate Enforcement Action

By Kurt R. Karst – On September 19th, FDA announced the issuance of a revised version of the Agency's June 2006 final guidance document/Compliance Policy Guide ("CPG") (FDA Docket No. 2003D-0478), titled "Marketed Unapproved Drugs – Compliance Policy Guide Sec. … Continue reading

Posted in Products Liability | Tagged , , , , , , , , , , , | 2 Comments

New FAA Guidance on Suspected Unapproved Parts

The FAA has updated the SUPs AC: Detecting and Reporting Suspected Unapproved Parts, FAA AC 21-29C CHG 2 (August 17, 2011). Read more detail on Recent Aviation Law Posts –

Posted in Aviation Law | Tagged , , , | Leave a comment