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
Non-malignant hematology, respiratory and cardiometabolic candidates make up for an unusual lack of oncology products on the US FDA’s December user fee goal calendar.
Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.
A subfield of AI aims to explain why complex models make predictions, which will increase their interpretability and auditing ability, AI researcher Su-In Lee said during a National Academies of Sciences workshop.
A subfield of AI aims to explain why complex models make predictions, which will increase their interpretability and auditing ability, AI researcher Su-In Lee said during a National Academies of Sciences workshop.
The orphan drug share of US FDA’s 2025 novel approvals is holding steady, with examples of approvals based on a single trial with confirmatory evidence from UCB, Precigen, Jazz Pharmaceuticals and Stealth Biotherapeutics
A cluster of CRLs for rare disease applications based on one trial plus confirmatory evidence may represent a shift away from the regulatory flexibility that had come to characterize ultra-rare drug development