Latest from Bridget Silverman
Former Food and Drug Law Institute CEO Amy Comstock Rick will take on patient engagement for the US FDA Rare Disease Hub as director of strategic coalitions.
US FDA’s Rare Disease Innovation Hub should shepherd the practical transformation of the diverse wealth of patient-generated data held by advocacy organizations into information for regulatory use, Reagan-Udall public meeting hears.
Another record-breaking year for novel approvals looks out of reach, but the six novel agents with November goal dates show the continued strength of rare disease drug development.
New nods for Boehringer Ingelheim’s survodutide, Sagimet’s denifanstat and Mirum’s volixibat bring the FDA’s non-infectious liver disease breakthrough therapy designations to 15, with six designees already approved.
Slow adoption of alternatives to animal testing in the current decentralized regulatory framework.
Slow adoption of alternatives to animal testing in the current decentralized regulatory framework shows the need for a ‘one-stop shop’ at FDA that can provide advice, precedents and qualification programs.