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
The US FDA will seek industry feedback on the Commissioner’s National Priority Voucher pilot during a June public meeting as the ultra-fast drug review program marks its first year amid growing scrutiny of its scope, timelines, and sponsor obligations.
Pink Sheet editors discuss the impact of a federal judge’s decision that the recent ACIP membership turnover and vaccine schedule changes likely violated statutes, as well as the FDA’s look at new opioid disposal requirements.
With the US CDC Advisory Committee on Immunization Practices sidelined by the courts, the Pink Sheet imagined how a past version of the panel may have spent the spring, including tracking a fast‑moving pipeline of flu, RSV, Lyme, dengue, and next‑generation combination vaccines.
The agency is conducting further investigation of reports of altered skin sensation that occurred more frequently with the 7.2 mg semaglutide dose than with lower doses of the GLP-1 inhibitor.
Vaccine manufacturers warned the FDA vaccines advisory committee that international genetic resource rules are delaying influenza virus sharing and creating regulatory hurdles that could undermine seasonal vaccine preparedness.
Pink Sheet editors discuss the direction of the FDA and CBER after Vinay Prasad’s exit, CBER’s similarities to the Harry Potter saga, as well as the Real-Time Oncology Review pilot’s contributions to Commissioner’s National Priority Voucher approval times.