FDA Sticks To Guns In Final Guidance On Production Changes

Law360, New York (March 4, 2014, 8:17 PM EST) -- The U.S. Food and Drug Administration on Tuesday finalized guidance describing the types of low-risk drug manufacturing changes that only need to be reported annually, backing away from a few proposals that companies deemed burdensome but declining for now to consolidate scattered policies on the subject.

In its guidance, the FDA discussed post-approval changes to a drug that are unlikely to affect product safety or effectiveness and therefore can be disclosed on a yearly basis. By contrast, more dramatic changes can require advance authorization from the...
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