Tag Archives: Unapproved

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

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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

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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 –

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