Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 15 January 2015 | By Alexander Gaffney, RAC
The US Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is already off to a busy start this year, having released new long-sought functions on its website, launched its new Office of Pharmaceutical Quality (OPQ) and hired a permanent director for its Office of Generic Drugs.
The changes, it seems, aren't stopping there. Last week, CDER also announced a reorganization of its Office of Management in the hopes of streamlining its approach to managing the nation's drug regulators.
In an email to FDA staff on 8 January 2015, CDER Director Janet Woodcock said the new management staff will include two additions: a strategic programs and initiatives staff, and an ethics liaison staff.
The overall will also see the creation of two new divisions:
A third division, the Division of Management Services (DMS), which oversees most of CDER's HR functions, will continue to exist with some minor changes. CDER also said it plans to eliminate a total of six branches:
Woodcock said the reorganization will help CDER to "better meet the management services needs of a growing Center with expanding authorities" under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012.
Tags: Office of Management, Janet Woodcock