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 Conducts Seminar for FDA Fellows

FDA alumni and FDAAA members conduct a panel for the FDA Fellows. From left are Bill McConagha, Susan Winckler, Nancy Myers, Jeanne Ireland, Mark Elengold, Florence Houn, and Wayne Pines.

FDA historian Suzanne Junod presents to the FDA Fellows a brief history of the Agency.

Steven Grossman of the Alliance for a Stronger FDA discusses the FDA budget.

FDAAA has conducted an annual educational seminar for the FDA Fellows for about half a dozen years. This year's session was on January 6 at White Oak.

The Fellows program provides a means of attracting and training future FDA employees. The Fellows work throughout the Agency during their program. FDAAA members Nancy Myers and Wayne Pines have organized the annual educational seminar at the invitation of the FDA.

The agenda in January 6 included a presentation by FDA historian Suzanne Junod summarizing the history of FDA; a panel of FDA alumni who discussed their experiences at FDA; and a presentation on FDA's budget by Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, an independent organization that has advocated on behalf of the. Agency's budget for the past decade.

The FDAAA members who participated in the alumni panel were FDAAA members Mark Elengold, Florence Houn, Jeanne Ireland, Bill McConagha, Nancy Myers, Wayne Pines, and Susan Winckler.

Some of the themes emphasized by the alumni were the importance of FDA work, the mission orientation of FDA employees, and the advantages of networking while working at the Agency.

The session was teleconferenced to Fellows unable to attend.

Reception for Chiefs of Staff

FDAAA sponsored a cocktail reception December 3 honoring FDA chiefs of staff (or their equivalents). The event took place at the offices of Covington and Burling in downtown D.C.

As you can see from the photos the event was well attended and gave the attendees a chance to mingle and reminisce. Acting Commissioner Stephen Ostroff joined the gathering.

Sponsors for the event included the Biotech Policy Group, Catalyst Healthcare Consulting, Covington and Burling, EAS Consulting, Greenleaf Health, Hogan Lovells, Keller and Heckman, and former FDAer and FDAAA member Dr. Murray Lumpkin.

This is the second year that FDAAA has sponsored a December reception for members. The 2014 reception honored former and current Center directors.

Former chiefs of staff (or equivalent) gather for a photo with FDAAA officers. See if you remember these faces and names: (left to right) Ed Steele (FDAAA), Tom Kraus, Susan Winckler, Tom Grumbly. Molly Muldoon, Stuart Pape, Acting Commissioner Stephen Ostroff, Joe Levitt, Lisa Barclay, and Nancy Myers (FDAAA).

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Vacancy Announcements for Key Alumni Association Positions

The FDA Alumni Association is looking to fill the following three positions with members willing to contribute to the continued growth of the Food and Drug Alumni Association. These are senior positions within the leadership of the FDA Alumni Association. Each is an unpaid volunteer position, allowing incumbents to work with a dynamic team of former FDA leaders. Applicants must be an FDAAA Member in good standing. Applicants should be willing to devote several hours per month to the duties described below.

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Recent Luncheon November 6, 2015

Celia M. Witten, Ph.D., M.D. CBER's Director, Office of Cellular, Tissue, and Gene Therapy, spoke at an FDAAA lunch on November 6 about advance in gene therapy and how FDA is approaching regulation. This was one of a series of lunches that the FDAAA sponsors during the year, featuring leading FDA officials.

FDAAA International Network Featured at 51st Annual DIA Meeting

By Ekopimo Ibia, MD, MPH

Drs. Murray (Mac) Lumpkin, Ekopimo Ibia, and Rizwan Ahmad

L to R: Drs. Murray (Mac) Lumpkin, Ekopimo Ibia, and Rizwan Ahmad

Over the last decade, there have been widespread activities by nations, nonprofits, and industry to optimize global regulatory capacity, particularly in low and middle-income countries (LMICs). At the 51st Annual DIA meeting recently held in Washington, D.C., FDAAA International Network (FDAAAIN) hosted a session to highlight some of the progress made to date and opportunities for further improvement in global regulatory capacity.

Ekopimo Ibia, MD, MPH, FAAP (Co-Chair of FDAAAIN and Director, Medical Safety Review, Merck & Co., Inc.) chaired the session, titled "Progress Report on Emerging Nations and Regulatory Capacity Building." Highlights of the session included (a) the evolving effort to establish good reliance practices as an international best practice for a more efficient use of available global regulatory capacities, (b) the commendable progress toward setting up functional Regional Centers of Regulatory Excellence (RCORE) in sub-Sahara Africa, and (b) the recommendation for a systems approach to dealing with the challenges inherent in regulatory optimization efforts.

Former FDAer Dr. Murray (Mac) Lumpkin, MD, MSc (Deputy Director, Regulatory Affairs, Lead Global Regulatory Systems Initiatives, Bill and Melinda Gates Foundation, USA) kicked off the session with a presentation on regulatory systems optimization in LMICs. A major challenge in such countries, he said, is that the pharmaceutical access systems are often "open," loosely regulated, multifaceted, and complex with insecure supply chains and significant gaps in capacity, leading to long delays in patient access to quality medicines, and resulting in products of uncertain quality, safety, and efficacy being readily available to patients.

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FDAAA International Network Active at China DIA Meeting

The FDAAA International Network (FDAAAIN) participated actively at the 2015 China Drug Information Association(DIA) Annual Meeting in Shanghai.

FDAAA is fortunate to have a very active and engaging International Network. The FDAAA provides a platform for the Network to conduct its many activities. The stories from Shanghai highlight the members of the Network - contact any of them for more information.

Here are the links to four stories and photos from the Shanghai meeting:

Links to Recent FDAAA Events and Announcements

Recent FDAAA Events

  • FDAAA Conducts Seminar for FDA Fellows (01/09/16)
  • Reception for Chiefs of Staff (12/10/15)
  • Luncheon November 6, 2015 (11/06/15)
  • FDAAA International Network visits with CFDA Officials and BioBAY Entrepreneurs (08/03/15)
  • Dr. Florence Houn Receives DIA China Excellence in Service Award (08/03/15)
  • FDAAA International Network Expands Footprint at 2015 DIA China Annual Conference in Shanghai China (08/03/15)
  • FDAAA International Network hosts an "FDAAA and Friends Night" event in Shanghai (08/03/15)
  • FDAAA International Network Featured at 51st Annual DIA Meeting (08/01/15)
  • Andrew Bonanno Receives FDA Distinguished Alumni Award (06/29/15)
  • Michael Taylor Receives FDAAA Wiley Award (06/28/15)
  • 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)
  • Announcements