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.

FDAAA Launches New Year at Annual Meeting

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.

Vol of the year

Dan Michels, former Director of Compliance at CDER, accepts the Volunteer of the Year Award from FDAAA Chair Nancy. Myers.

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FDAAA Elects New Board Members, Names Officers

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

FDA and FDAAA to Collaborate on Pilot Alumni Advisor Program

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).

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FDAAA Luncheon with FDA CDER Center Director, Janet Woodcock, MD, April 2, 2015

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.

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Latest Announcements

New! FDAAA Annual Report 2014

Annual Report

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 ckarst@raps.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).

Links to Recent FDAAA Events and Announcements

Recent FDAAA Events

Announcements

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