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FDA suspends GMP requirements on trial drugs
The FDA has issued new guidelines that exempt Phase I drugs from certain Good Manufacturing Practice regulations. In issuing the exemptions--which go into effect September 15, the agency notes that GMP regulations were designed more for commercial manufacturing than for investigational products designed for a Phase I trial. The FDA's new guidelines mimic the same approach adopted two years ago which were suddenly withdrawn before taking effect.
FDA News notes that Phase I products will no longer have to meet GMP requirements for "a fully validated manufacturing process, rotation of stock for drug product containers, repackaging and relabeling of drugs and separate packaging and production areas."
- read the report from FDA News
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