Scrip 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

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 Offers More Advice On Mid-Trial Changes For Pandemic-Impacted Studies

A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.

US FDA To Exercise ‘Maximum Regulatory Flexibility’ For COVID-19 Plasma-Derived Therapeutics

Agency is working with manufacturers, including Takeda and Emergent BioSolutions, to accelerate development of hyperimmune globulin products, with an eye toward starting clinical testing in several months; new FDA guidelines on convalescent plasma collection for single-patient emergency IND use are helpful in understanding agency expectations around source plasma collection for manufactured products as well, Emergent SVP Laura Saward says.

US Marks Biologics Transition Day

Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.

Topics

UsernamePublicRestriction

Register

SC005447

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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