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

FDA’s Office Of Regulatory Affairs To Be Headed By Agency Veteran

This article was originally published in The Pink Sheet Daily

Executive Summary

Melinda Plaisier, who has been acting Associate Commissioner for Regulatory Affairs for the past year, was named to the position; appointment comes following several leadership changes in ORA.

You may also be interested in...



FDA’s Autor Moves To Mylan: Company’s Gain May Also Be Company’s Loss

While Mylan wants Autor to help push quality improvement efforts around the world, her departure from FDA may affect implementation of similar plans at the agency.

CDER’s New Compliance Director Sklamberg Brings Experience On Compounding Issues

Howard Sklamberg, deputy associate commissioner in FDA’s Office of Regulatory Affairs, will take over as director of the Center for Drug Evaluation and Research’s Compliance Office in January; acting compliance director Ilisa Bernstein will resume her role as deputy director.

FDA Office of Regulatory Affairs Make-Over Blends Domestic, International Work

The reorganized ORA has eight new offices to better handle new legislative authorities and globalization of its regulated products; FDA expects to increase partnerships with other government officials and foreign entities.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS076331

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