Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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

Oh NOOH! Vanda’s Multi-Front Battle With US FDA Extends To Insomnia Drug Hetlioz

The notice of opportunity for hearing on the US FDA’s proposal not to approve an insomnia sNDA for Vanda’s Hetlioz opens another front in the company’s aggressive campaign against complete response letters and generic competition to the sleep disorder drug.

Drug Approval Standards Review Pathway

Lykos’ MDMA Trial Conduct Allegations Influence US FDA Advisory Committee

Safety concerns related to MDMA patient suggestibility and impairment troubled the panel reviewing psychedelic therapy for PTSD, although the FDA advised that therapist misconduct is outside its control.

Advisory Committees Drug Review

Therapy Component Trips Up Lykos’ MDMA At US FDA AdComm For PTSD

Functional unblinding and vague psychotherapy guidance lead to two negative votes for Lykos’ pioneering psychotherapy-assisted psychedelic therapy at the US FDA’s Psychopharmacologic Drugs Advisory Committee.

Advisory Committees Drug Review

Lykos’ MDMA Heads To AdComm With US FDA Concerns About Adverse Event Reporting

‘Short-term effects of midomafetamine were not captured’ in the clinical program for post-traumatic stress disorder, FDA notes. Proposed REMS for the psychedelic therapy to be discussed at 4 June would limit dispensing setting, restrict post-treatment driving.

Advisory Committees Drug Safety

US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer

June goal dates include RSV and pneumococcal vaccines, two COPD therapies, Rocket and Sarepta gene therapies, and lots of oncology.

US FDA Performance Tracker Drug Review

US FDA’s Novel Approvals Peak Near Year-End, Analysis Of Last Decade Suggests

The Center for Drug Evaluation and Research’s novel approvals concentrated in August, November, and December, while January and June were the slowest months, according to a Pink Sheet analysis of 2014-2023 data.

Approvals US FDA Performance Tracker
See All
UsernamePublicRestriction

Register