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.
Rescheduled - FDAAA Lunch and Learn Event - Now MAY 28th!
The topic is FDA activities relating to the Ebola virus. We are fortunate that both Dr. Lu Borio, FDA's Acting Chief Scientist, and Dr. Ed Cox, Director of the Office of Antimicrobial Products in CDER, have agreed to join us on May 28th to share their insights and experience.
- NEW Date: Thursday, May 28, 2015
- Time: 10AM-12PM; our speakers will join us from 10:30 - 11:30 AM
- Event Type: Lunch and Learn, Brown Bag (bring your own lunch, if desired; drinks and dessert will be provided)
- Speaker: Drs. Lu Borio and Ed Cox will talk about FDA activities related to Ebola
- Location: FDA White Oak Campus, Building 1, Conference Room 2102 (enter through Main entrance of Building 1; gather as a group and someone from FDA will escort all to the Conference Room)
- Address: 10903 New Hampshire Avenue, Silver Spring, MD 20993
- Parking: Parking can be very challenging at White Oak; please allow extra time to find a spot and/or carpool if possible
- Cost: $10 - payable online (on our FDAAA web site, www.fdaaa.org)
- RSVP: Jayne Ware at Jayne.Ware@Merck.com
Save the Date for the Spring Fling, June 2
The annual Spring Fling will take place June 2.
- What: 6th Annual Commissioner's Spring Fling to Celebrate Acting Commissioner Dr. Stephen Ostroff
- Invitees: FDAAA Members only (no outside guests for this one)
- When: June 2: 12pm-1:30 PM
- Where: FDA White Oak campus, Great Room, Building 31
- Logistics: Parking will be available in the visitors lot with usual FDA shuttle buses to Building 1 security entrance.
- Caterer: Red Hot and Blue BBQ
- RSVPs Before May 28th to Deb Henderson
- If you prefer a vegetarian wrap, please let us know this so we can accommodate this.
- Cost: Members $55
Associate members: $35
Members can pay by Pay Pal or bring a check. Cancellations must be received 48 hours before the event to avoid billing.
A new year for FDAAA was launched at the annual meeting April 20. Nancy Myers, FDAAA chair, summarized the past year's many accomplishments during 2014, which are listed in the Annual Report, and expressed optimism that 2015 would be even more productive and valuable for members.
Nancy said the biggest accomplishment in 2014 was the appointment of new chairs for the various FDAAA committees, which provides a strong core of talent to lead the association in 2015.
The FDAAA held its first Board meeting on April 20 following the Annual Meeting.
The Board elected the following officers:
- Edward Steele, President
- Andrew Bonanno, Vice President
- Michael Olson, Treasurer
- C.K. Gund, Secretary
- Jessica O'Connell, General Counsel
The following members were elected to the Board:
- Andrew Bonanno
- David Chesney
- Florence Houn
- Edward Steele
- Marie Urban
FDAAA and FDA are partnering on a pilot "FDA Alumni Advisor Program" that will match selected Office of Regulatory Affairs (ORA) participants with former senior FDA leaders in a mentoring relationship.
The pilot program is part of the FDA's Division of Human Resource Development's (DHRD) Management and Leadership Development Program (MLDP).
By: Jayne Ware
The FDA Alumni Association celebrated Spring on April 2nd with an outstanding luncheon, featuring lively fellowship and a favorite FDA speaker. Over 35 FDAAA members attended the luncheon at Mrs. K's Toll House in Silver Spring, Maryland, and received a treat: a visit with Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER). For more than a decade, Janet has been highlighting the need for an overhaul of pharmaceutical quality regulation and seeking buy-in and alignment from leadership in other corners of the Agency. Janet was happy to report that a key piece of that overhaul is in place: an organizational transformation of the Center's business units involved in regulating drug quality. The transformation (a.k.a. an "administrative nightmare") involved a reorganization, consolidating the pharmaceutical quality functions previously housed in the Office of Pharmaceutical Science, the Office of Generic Drugs, the Office of Manufacturing and Product Quality, and the Office of Compliance, into a single organization.
New! FDAAA Annual Report 2014
See a summary of 2014 of the year
For your Alumni Association
Opportunity: RAPS Seeks Regulatory Experts
The Regulatory Affairs Professionals Society (RAPS) is seeking senior/executive regulatory affairs experts to volunteer in updating the regulatory professional competency framework.
Interested FDAAA members should contact Cindy Karst at firstname.lastname@example.org (phone 301.770.2920). When contacting RAPS, applicants should indicate their area(s) of expertise and preference for one of the two work groups (the small group of assessors or larger group of validators).
Recent FDAAA Events
- FDAAA Launches New Year at Annual Meeting (04/20/15)
- FDAAA Elects New Board Members, Names Officers (04/20/15)
- FDAAA Luncheon with FDA CDER Center Director, Janet Woodcock, MD, April 2, 2015 (04/10/15)
- FDAAA Holds End of Year Reception as a "Tribute to Center Directors – Past and Present" (12/2/14)
- September 14 FDAAA Luncheon with FDA CDER Deputy Center Director for Science Operations, Richard A. Moscicki, MD (10/27/14)
- FDAAA Sponsors Session on Clinical Research Enterprise in Africa, Asia, and South American at 50th US DIA Annual Meeting (07/16/14)
- Fifth Annual FDAAA Spring Fling - May 27, 2014 (06/15/14)
- Drs. Florence Houn and Zili Li, co-chairs of FDAAA's International Network received FDA's Distinguished Alumni Award at FDA's June 6th Award Ceremony (06/15/14)
- Update on FDAAA International Network Co-Chair Activities at DIA China, Shanghai China (05/22/14)
- FDAAA International Network Conducts GxP Training at DIA China, Shanghai (05/22/14)
- FDAAA International Network (FDAAA IN) Visits with China FDA Officials (05/22/14)
- The FDAAA's Annual Meeting and Board Meeting (05/05/14)
- Dr. Robert Temple Receives FDAAA's 2014 Harvey W. Wiley Award (05/04/14)
- FDA and FDAAA to Collaborate on Pilot Alumni Advisor Program (04/17/15)
- Opportunity: RAPS Seeks Regulatory Experts (03/10/15)
- FDAAA Praises Hamburg for Her Dedication To FDA's Mission and Looks Forward to Working with Dr. Stephen Ostroff Who Will Serve as Acting Commissioner (02/05/15)
- FDAAA Announces New Treasurer and Chairs for New Member Recruitment Committee (08/10/14)
- Dr. Beverly Corey, FDA's Senior Regional Advisor for Sub-Saharan Africa has passed away (08/09/14)
- FDAAA joins FDA in recognizing the 100th birthday of one of the Agency's most celebrated alumnus (07/29/14)
This individual page is maintained by Linda Tukenmez