POST-APPROVAL CHANGES IN OTC PACKAGING AND BULK TESTS THROUGH SUPAC sought by the Nonprescription Drug Manufacturers Association. Speaking at the group's annual Manufacturing Controls Seminar in Philadelphia Oct. 10-11, Manufacturing Controls Committee Chair Donald Cadge said: "It seems reasonable" that after providing and proving equivalency through FDA's Scale-Up and Post-Approval Changes guidance for immediate-release products, "it stands to reason that a company should also be able to keep all production in place but move the packaging and/or the testing of that bulk after proving equivalency." Cadge is with McNeil Consumer Products.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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