Objections Force FDA To Withdraw New Rules

Law360, New York (April 4, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration has withdrawn a set of good manufacturing practice regulations for the pharmaceuticals industry after the public comment period prompted a barrage of objections.

The move, announced Friday in the Federal Register, sets back the FDA's first step towards modernizing and clarifying the good manufacturing practices drugmakers must follow for finished pharmaceuticals and harmonizing its practices with those of other regulators around the world.

“FDA is withdrawing the direct final rule because the agency received significant adverse comments,” the agency's notice...
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