Bridget joined the Pink Sheet during the very first US Prescription Drug User Fee Act cycle and has maintained a focus on the US FDA’s drug review and approval process. Her role as managing editor of US regulatory analysis builds on her long experience at the Pink Sheet and its earlier affiliated publications Pharmaceutical Approvals Monthly and the NDA Pipeline. She oversees the Pink Sheet’s US FDA Performance Tracker suite of regulatory data, which also inform her coverage of drug development and clinical trial design. Bridget he is always interested in seeing how regulatory policy works out in practice and contributes to the Pink Sheet’s Drug Review Profile series. Outside of work, Bridget keeps track of her family, three dogs, and ever-expanding library of mystery novels.
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.