PET Drugs Without An IND Get Three More Years For Studies Under FDA Guidance
This article was originally published in The Pink Sheet Daily
Q&A document from agency says sponsor does not have to use the same manufacturing process as the reference listed drug.
You may also be interested in...
Keeping Track: Chugai Delivers Two Breakthroughs For Roche; FDA Continues To Wrestle With Opioid Regulation
The latest drug development news and highlights from our FDA Performance Tracker.
For positron emission tomography drugs with low levels of use that are needed to diagnose rare conditions, an expanded access IND may be the best regulatory pathway.
FDA will require commercial manufacturers of approved positron emission tomography drugs to meet new GMP requirements by Dec. 12, 2011. This marks the first time that FDA has mandated separate GMPs for a particular type of drug product