HBW Insight 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 Pediatric Therapeutics Office Could Fall Under ORM Purview

This article was originally published in The Tan Sheet

Executive Summary

FDA's Office of Pediatric Therapeutics would be located within the Office of Review Management under proposed organizational changes at the agency.

You may also be interested in...



CDER Deputy Director Galson To Head Drug Center For Several Months

Center for Drug Evaluation & Research Deputy Director Steven Galson, MD, will serve as the center's acting director for the next several months

FDA restructuring

Office of Pediatric Drug Development & Special Initiatives, forming Oct. 1, will be headed by ODE IV Director Dianne Murphy, MD. Division of Special Pathogenic & Immunologic Drug Products Director Mark Goldberger, MD, will take over as ODE IV acting director. The office will assist with pediatric drug policy and regulatory support, handle "initiatives related to the study and labeling of drugs in pregnancy" and serve as a liaison with external pediatric advocacy groups, CDER says. Originally slated to be the Office of Pediatric Therapeutics, the office reflects the upsurge in pediatric clinical trials following passage of FDAMA's pediatric exclusivity provisions (1"The Tan Sheet" July 16, p. 16)

Pediatric Labeling Negotiations Limited To Six Months In Reauthorization Bill

Negotiations for pediatric labeling changes would be limited to six months under a proposed bill to reauthorize the pediatric exclusivity provisions.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS132464

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