US FDA Urged To Stop Slowing Approvals By Seeking Metals Data From Suppliers
Excipient suppliers complain about agency requests for elemental impurities data that go beyond ICH and USP requirements and delay approvals.
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IPEC-Americas has proposed that FDA issue supplemental question-and-answer guidance to clear up confusion on what elemental impurity information FDA reviewers can ask of manufacturers and their excipient suppliers in connection with pending applications. The group said that generic manufacturers, primarily in India, “continue to have a significant number of questions and misunderstandings” of what elemental impurity information they are supposed to report to FDA.
Proposal could yield a bounty of new options for innovative drug delivery systems.
Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.