Scrip 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

FDLI makes leadership appointment

This article was originally published in Scrip

Executive Summary

The Food and Drug Law Institute (FDLI) has named former US FDA chief of staff Susan Winckler as the group's new president and CEO. She replaces James Kelley, who announced his departure in the summer. Ms Winckler is a pharmacist and attorney who served as FDA chief of staff from January 2007 to June 2009. She was most recently managing director of the medical products practice at Leavitt Partners, a consulting firm headed by former Health and Human Services secretary Mike Leavitt.

You may also be interested in...



US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios

Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.

Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works

FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.

ADHD Drugs: FDA Commissioner Blames Inappropriate Prescribing For Shortages

ADHD drug shortages may have resulted from industry reticence to fill DEA quotas, as well as a 'heavy element of professional responsibility' with off-label prescribing, Robert Califf told a House appropriations subcommittee.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

SC005447

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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