Pink Sheet 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

Drug Review Reorganization At US FDA Coming Into Focus

Executive Summary

Oncology, neuroscience, and infectious diseases get acting directors as the expansion and renovation of the Office of New Drugs moves into Phase II.

You may also be interested in...



2020 In Review: US FDA New Drug Office’s COVID-19 Response Aided By Reorganization

Office of New Drugs Director Peter Stein tells the Pink Sheet that last phase of massive reorg was complicated by pandemic restrictions that forced review staff to work remotely, but the structural overhaul resulted in smaller, more nimble review groups and the breaking down of silos that ultimately helped the agency’s response to the public health crisis.

US FDA Drug Office Reorg Enters Homestretch With Leadership Nods For Three Clinical Offices

Hylton Joffe was named acting director of the new Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine but also will continue to serve as Office of New Drugs acting deputy director; agency veterans Ellis Unger and Julie Beitz also tapped for clinical office leadership roles in final stage of massive reorg.

With Sarepta’s Vyondys, US FDA Staff Saw Opportunity To Right Perceived Wrongs With Exondys

ODE I director Ellis Unger chafed at the notion of approving the Duchenne muscular dystrophy drug golodirsen on the same unvalidated surrogate marker, this time in the face of infection and renal toxicity concerns; OND’s Peter Stein granted Sarepta’s appeal while also calling attention to the company’s failure to timely conduct the eteplirsen confirmatory trial.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS141147

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel