The US Food and Drug Administration is going overboard with unwarranted requests that excipient and drug substance manufacturers test their materials for elemental impurities, according to a leading figure in the pharmaceutical excipients sector.
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.
