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U.S. Notifications
United States of America (USA/361: Drugs, medical devices)
The Food and Drug Administration (FDA) is proposing to amend its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA) to codify the agency's view on when a change to the labeling of an approved drug, biologic, or medical device may be made in advance of the agency's review of such change.
Full Text
Final Comment Date: March, 17, 2008
(Texts provided by the World Trade Organization.)
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