Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Turnaround at FDA's Drug Center: An Interview with Janet Woodcock

This article was originally published in RPM Report

Executive Summary

Janet Woodcock returned to the Center for Drug Evaluation & Research after four years as FDA commissioner Andrew von Eschenbach's right-hand woman. We talked to her about why she went back, how things have changed and the challenges that lie ahead.

You may also be interested in...



Cost Effectiveness in the US? Round One Goes Against Pharma

The stimulus bill provides an unprecedented $1.1 billion for comparative effectiveness research-and does so with none of the key provisions biopharma companies hope to see as the US federal government takes a more active role in the field. The good news: this is only the first round, and there is reason to believe the field is evolving as most pharma companies would want. But this isn't the time for manufacturers to let their guard down.

FDA's Jesse Goodman is Rising Star Within Agency

For FDA's top biologics review manager, Jesse Goodman, the announcement of the membership list of the Federal Coordinating Committee on Comparative Effectiveness Research was also his debut in a new role: acting chief medical officer. His background in infectious diseases and preparedness aligns well with the topside leadership in FDA and HHS.

Separate But Equal: FDA Reaffirms Drug Safety Role in Approval Process

There's a new drug safety structure at FDA, with the Office of Surveillance & Epidemiology gaining greater influence in how the agency manages things like REMS and product withdrawals. In many ways, it's a codification of an existing relationship between safety and review officials. But some sponsors worry it will also result in a less friendly approval process.

Related Content

Topics

UsernamePublicRestriction

Register

PS080445

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