Late last month the Healthcare Distribution Alliance (HDA) submitted a letter to the FDA in response to the docket for the DSCSA Public Meeting held on February 28, 2018 (see “FDA DSCSA Public Meeting #3: A Difference?”). Like everyone who attends these meetings, HDA appreciates the FDA holding them. HDA recognizes the importance of clear and well-reasoned responses to every important discrepancy in interpretation their members heard during these meetings. You can tell from this and all previous HDA letters to the FDA regarding the Drug Supply Chain Security Act (DSCSA). This letter is another masterpiece, following previous HDA masterpieces (see “HDA Schools FDA On DSCSA” and “HDA Questions FDA’s Authority To Mandate A Centralized System For the EDDS”).
HDA’s letter about the third FDA DSCSA Public Meeting was a very effective deconstruction of eight of the ten items in FDA’s list of “Enhanced Security Needs” summarized Continue reading HDA Urges FDA…Please Re-Read The DSCSA