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
Medical device sponsors can use real-world evidence without submitting identifiable patient-level data under a new guidance that is expected to expand to drugs and biologics.
The first approval under the Commissioner's National Priority Voucher, a re-introduction of domestic production of an antibiotic, took two months to clear, but the timeline will be more challenging for the three pending CNPV applications with efficacy claims.
Saol Therapeutics cannot conduct a new clinical trial of SL1009 in ultra-rare mitochondrial disorder, but aims to answer the FDA's complete response letter with new looks at available data.
After voting to change the recommendation for a hepatitis B vaccine birth dose, the CDC Advisory Committee On Immunization Practices laid the groundwork for for changes to adjuvant policy.
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.