FDAAA serves FDA alumni by providing communications, holding functions, listing opportunities, and much more. Serving those who have served also takes the form of helping those who still are serving, the current staff at FDA.
Welcome Message
Welcome to the Food and Drug Administration Alumni Association (FDAAA) website.
I am honored to serve as the new President of the FDAAA. Following on the heels of Dr. Alan Andersen will be a challenge since he set a standard that will be difficult to match. However, I am committed to do my very best to serve the needs of all FDAAA members. This not only includes those in the Washington DC area, but those scattered throughout the US and abroad. I am particularly committed to increase the services and to gain the active participation of those who are serving and have retired from the various FDA field offices. I will work hard to help grow the Association and to support its mission of helping alumni stay in touch with the issues of the day facing the FDA and support the agency's public health mission through expertise and experience-sharing, training and outreach opportunities. [more]
Upcoming Events
Outside the Beltway Cocktail Reception in Boston
Come Meet with Friends and Colleagues Past and Present at the FDA Alumni Association's First Ever, Outside the Beltway Cocktail Reception in Boston
- Who: FDA Alumni and current FDAers
- When: Tuesday, June 25th from 6-8 PM
- Where: Luckys Lounge: 355 Congress St., Boston
A short 5-minute walk from the DIA Annual Meeting and the Boston Convention Center - Registration: RSVP to Nancy Myers nancy@catalysthcc.com
- Payment Options:
-
Check: Make check payable to the
Food and Drug Administration Alumni Association - New Chairman for the Nominating Committee
(06/14/13) - FDAAA International Network Holds Successful One-Day Clinical Workshop On a Case Study of Benefit-Risk Regulatory Decision-Making with the Center for Drug Evaluation, Taiwan, on May 10, 2013, Taipei (06/06/13)
- FDAAA International Network Leads Eight Major Regulatory Sessions at 4th Annual Drug Information Association China Meeting on May 13-15, 2013, Beijing (06/06/13)
- FDAAA International Network Co-sponsors 5th Annual Workshop on Regulatory Science-Based Decision Making for China's State FDA's Center for Drug Evaluation on May 17, 2013, Beijing (06/06/13)
- FDAAA Annual Meeting Highlights, Mark Elengold (05/27/13)
- Harvey W. Wiley Lecture Presented by Richard M. Cooper at the FDLI Annual Conference (04/23/13)
- FDAAA Luncheon - Richard Pazdur, M.D., Director, Office of Oncology and Hematology Drugs (3/7/13) (3/18/13)
- FDAAA Frances Kelsey Award Celebration (12/19/12)
- FDAAA Participates in APEC's Advanced Workshop of Good Review Practices, Visits China's State FDA Center for Drug Evaluation (11/27/12)
- FDAAA Luncheon - Lou Valdez, Associate Commissioner for International Programs and Director of the Office of International Programs (OIP) (11/14/12)
- Celebration of the Drug Amendments Act of 1962 — October 17, 2012 (10/22/12)
- FDA Alumni Association Receives Prestigious Frances O. Kelsey Award (10/10/12)
- Workshop on Building a Professional Regulatory Workforce in Developing Countries September 19, 2012, Washington, DC (09/27/12)
- FDAAA Luncheon, August 1, 2012 - Jeanne Ireland, Associate Commissioner of the Office of Legislation. (08/23/12)
- Deputy Commissioner Deborah M. Autor to Leave the Agency on June 1st (05/06/13)
- Passing of George Miller Burditt (2/20/13)
- James Morrison New Chair of FDAAA Member Services Committee (2/20/13)
- October 2, 2012 — Commemoration of the Drug Efficacy Amendments of 1962 (09/24/12)
- FDAAA Board Member Nancy Myers Receives FDA Distinguished Alumni Award (08/23/12)
Send Payment to
Nicholas Buhay
1612 Crestline Road
Silver Spring, MD 20904
FDAAA's Where Are They Now?
This is a reminder that we have started a new feature to help connect FDAAA members with former FDA friends and colleagues, called "Where Are They Now?" As previously mentioned, we want to build better communications and connectivity among our members and our goal is to let other FDA Alumni know what's going on since we retired from FDA. We will continue to periodically post photos of FDAAA members and their personal and professional updates since leaving the agency in my "Updates" and on the FDAAA website (see "Where are They Now?" on the website).
Latest Events
FDAAA International Network Holds Successful One-Day Clinical Workshop On a Case Study of Benefit-Risk Regulatory Decision-Making with the Center for Drug Evaluation, Taiwan, on May 10, 2013, Taipei
On May 10, 2013, the FDAAA International Network sponsored an educational workshop for the Center for Drug Evaluation, Taiwan. The workshop's goal was to understand the foundation and application of science-based decision-making principles in the US FDA, to understand risk/benefit tools used in regulatory decision-making and to understand the importance of good review practice, including good communication between industry and regulatory agencies by using a case-based approach to learning. The instructors for the workshop were: Dr. Zili Li (FDAAAIN co-chair), Dr. Florence Houn (FDAAAIN co-chair) and Dr. Mark Goldberger (FDAAA member). The attendees were the clinical reviewers of CDE, Taiwan. The workshop involved small group assignments, presentations by groups and role playing.
FDAAA International Network Co-sponsors 5th Annual Workshop on Regulatory Science-Based Decision Making for China's State FDA's Center for Drug Evaluation on May 17, 2013, Beijing
To further advance the establishment of science-based decision-making process as a foundation for regulatory review decisions in China, the State Food and Drug Administration's (CFDA) Center for Drug Evaluation (CDE) organized, "The 5th Annual Workshop on Regulatory Science-Based Decision-Making," at CDE headquarters on May 17, 2013. This year’s theme was Building Review Function Excellence: Management and Communications Challenges and Opportunities. The event was co-sponsored by State Food and Drug Administration (CFDA)/China Center for Pharmaceutical International Exchange (CCPIE), and the FDA Alumni Association International Network (FDAAAIN). The CDE senior management and entire review staff attended the workshop.
[more]
FDAAA International Network Leads Eight Major Regulatory Sessions at 4th Annual Drug Information Association China Meeting on May 13-15, 2013, Beijing
At the 5th Annual Drug Information Association (DIA) China conference held May 13-15, 2013 in Beijing, the FDAAA International Network (FDAAAIN) ran eight important regulatory sessions: Balancing Risk and Benefit During the IND Period, Balancing Risk and Benefit During NDA and Postmarketing Periods, Ensuring Innovation and Safety for Cell/Gene Therapy and Blood Products, Evaluation of Generic Products vs. Reference Products - the 2007 Conundrum, Regulatory Perspectives on Botanical Drug Products in China and the US, Pharm/Tox: from Animal to Man, GLP Regulatory Compliance for Data Quality and Integrity, and Principles for Pandemic Influenza Preparedness and Post-Marketing Vaccine Manufacturing Changes.
[more]
Latest Announcement
Deputy Commissioner Deborah M. Autor to Leave the Agency on June 1st
In a recent letter to all FDA Colleagues, Commissioner Margaret Hamburg announced the departure of Deborah M. Autor, Deputy Commissioner for Global Regulatory Operations and Policy (GO), after 18 years of dedicated federal government service, including 11 years spent at FDA. She will be leaving to take the position of Senior Vice President, Strategic Global Quality and Regulatory Policy at Mylan, Inc. In her letter, the Commissioner praised Deputy Commissioner Autor for her oversight of various critical programs within the Agency including, most recently, the GO Directorate. "In that role, Deb has led the implementation of FDA's strategy for addressing the challenges of globalization and import safety, including the paradigm shift that FDA must make to meet the challenges of globalization today and in the future through global coalitions, global data systems, advanced risk analytics and leveraging of the efforts of public and private third parties." John M. Taylor, III, currently the Counselor to the Commissioner, will serve as Acting Deputy Commissioner for Global Regulatory Operations and Policy until a permanent replacement can be found.
[more]
Links to Recent FDAAA Events and Announcements
Recent FDAAA Events
Announcements
This individual page is maintained by Linda Tukenmez