Food and Drug Administration

Experimental Drugs Released from GMP regulations

FOOD DRUGS ADMINISTRATION

FOOD DRUGS ADMINISTRATION

Experimental drugs in Phase I development will be exempt from some good manufacturing practice (GMP) regulations, according to a final rule published by the FDA. Both small molecule drugs and biologicals were covered on Sept. 15, 2008. The agency has also issued a guidance document containing recommended approaches for complying with those GMP requirements that still apply to these drugs.

Sourced and published by Henry Sapiecha Feb 2009

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