Bridget Silverman

Bridget Silverman

Managing Editor, US Regulatory Analysis

Washington, DC

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

Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

Business Background Of New CDER Director George Tidmarsh

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.

Don’t Look Back: US FDA AdComm Offers No Flexibility For Rexulti’s Post Hoc Bid In PTSD

The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Otsuka/Lundbeck’s Rexulti PTSD Claim Will Test US FDA AdComm’s Supportive Evidence Flexibility

Rexulti’s post-traumatic stress disorder sNDA tries to make up for a failed Phase III study by placing a Phase II study into a key evidentiary role, raising questions for the July 18 advisory committee meeting about assessing discordant results and post-hoc analyses.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.