M. Nielsen Hobbs
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Latest From M. Nielsen Hobbs
Association for Accessible Medicines’ interim leader is General Counsel Jeffrey Francer; Chip Davis’ four-and-half year tenure included a total rebrand of the association, a significant legislative victory with the CREATES act – and an abrupt departure for the Healthcare Distribution Alliance.
PDUFA and GDUFA negotiations are expected to begin first, as they usually take the longest to complete, and will be followed by BsUFA talks.
Healthy Adult Opportunity initiative (don’t call it block grants) adopts some, but not all, of Medicare Part D’s protected classes, allowing states to exclude some drugs from coverage in the expansion Medicaid population to drive additional savings.
US FDA’s drug shortage team continues to check in with sponsors, but so far the infections and quarantines have not impacted drug production.
US FDA draft guidance says that ‘minor differences’ in transgenes and/or vectors won’t be enough for orphan exclusivity, but agency will consider ‘additional features of the final product’ in making the determination.
Next PrecisionFDA challenge aims to detect ‘adverse event anomalies’ including manufacturer-specific patterns and drug-drug interactions.