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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

Keeping Track: Pfizer’s Zavzpret Brings Nasal Delivery To CGRP Antagonists; Ionis/AZ Advance Antisense Eplontersen In ATTR

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Approvals US FDA Performance Tracker

Lessons Still To Learn: Cytokinetics’ Omecamtiv Is Over In The US, But FDA Debriefs Could Inform European Strategy

Cytokinetics will not conduct the new trial in heart failure with reduced ejection fraction (HFrEF) required by the FDA’s complete response letter for omecamtiv mecarbil.

US FDA Performance Tracker Rare Diseases

Keeping Track: Opdivo, Keytruda Continue Adjuvant Push As Cancer Dominates Recent Applications

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Cancer US FDA Performance Tracker

Reata’s Skyclarys Approval Aided By Natural History And Delayed-Start Analyses

The first treatment for the rare neurodegenerative disorder Friedreich’s ataxia relied on a single placebo-controlled efficacy trial.

US FDA Performance Tracker Rare Diseases

After ACIP Gambit, Pfizer, GSK Take RSV Vaccines To US FDA Adcomm

The Vaccines and Related Biological Products Advisory Committee is scheduled to consider the RSV vaccine candidates on 28 February and 1 March.

Vaccines Infectious Diseases

Nasal Naloxone On Brink Of OTC Among Additional Opioid Overdose Options On US FDA's Plate

Upcoming goal dates for Emergent’s Narcan and Harm Reduction Therapeutics’ RiVive will test the US FDA’s efforts to nurture the over-the-counter naloxone switch, followed by decisions on higher strength nasal opioid antagonist products from Opiant and Orexo to address fentanyl and other synthetic opioids. 

Prescription To OTC Switch FDA
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