Medtech Insight 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


Hamburg looks to restructure FDA for consistency

This article was originally published in The Silver Sheet

Executive Summary

FDA Commissioner Margaret Hamburg says she wants to restructure the agency's front office to be more "internally consistent," according to a June 29 memo obtained by Elsevier Business Intelligence. "Various programs in the Office of the Commissioner are sited across that organization with little underlying rationale for their placement," the commissioner writes in a reorganization proposal to Health and Human Services leadership. The memo lays out a plan to streamline the development of the agency's budget, refine the chief scientist's mission and create new offices to fill gaps and bring related activities in closer contact. The proposal would not impact the structure or leadership of CDRH. The affected office with perhaps the most device-specific responsibilities is the Office of Combination Products, which would no longer report to the agency's chief scientist, but instead move to a new Office of Special Medical Programs focused exclusively on "cross-cutting medical programs.

You may also be interested in...

US FDA Still Seeking Sponsor Cooperation For Oncology Label Updates

Oncology Center of Excellence is reviewing a research report on fluorouracil, and will next look to update cisplatin's label, but eventually must convince the reference product sponsor to submit the changes.

Oncology Drug Safety Is Key Focus In US FDA’s Generic Label Updates

US FDA’s ‘Project Renewal’ requires lots of work and flexibility, Oncology Center of Excellence acknowledges. Side-benefit may be getting outside physicians to appreciate the value of drug labeling.

EU GMP Annex I Proposal Would Maintain PUPSIT, Relax WFI Restrictions

The pharmaceutical industry would lose bid to eliminate PUPSIT but win relaxed WFI in proposed EU GMP Annex I revision.





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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