Email addresses: Please be sure FDAAA has your current email address. Please check the directory on this web site to make sure. If your email address is outdated, or if you do not receive periodic FDAAA Updates from Alan Andersen, please let Karen Carson know. (kdlmc@aol.com)

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.

FDLI Annual Meeting and FDAAA's Wiley Award

Dr. Mark McClellan, former Commissioner of the FDA and CMS Administrator, was chosen by the FDAAA Board of Directors as this year's 2016 FDAAA Harvey Wiley Lecture Award Recipient. He will offer a lecture on May 6th from 12:30-1:45 PM at the FDLI annual meeting. This will be held at the Renaissance Downtown Hotel - 999 9th Street NW - Washington, DC 20001. http://www.fdliannual.com/agenda/

Special pricing for FDAAA members is available to attend the lunch and the whole day:

  • Attending just the Wiley Lecture Luncheon? $65 for FDAAA members.
  • To attend the entire day May 6th, the cost is $995.

To register for either option, please contact Michael Sprott at mms@fdli.org or 202-222-0891 and identify that you are an FDAAA member.

Come to the Spring Fling

Invitees: FDA Alumni Association Alumni and Associate Members (sorry, no outside guests for this one).

When: Wednesday, May 18th, Noon to 1:30 PM.

Where: Great Room at FDA's White Oak campus (10903 New Hampshire Avenue, Bldg 31, Silver Spring, MD 20903.

Logistics: Parking will be available in the visitors lot. FDA shuttle buses will take you to the Building 1 security entrance. Parking is tight, so leave time for campus bus transportation. Anyone with a disability, please let us know. We are working on a reserved spot or two -- though the spaces may not very convenient.

Caterer: Red Hot and Blue BBQ. Any vegetarians, please let us know at least one week in advance.

Cost: $55 alumni members; $35 associate members.

Please RSVP to Rachel Turow. RCTU@novonordisk.com.

FDAAA's Annual Meeting and Board Meeting will follow in a nearby conference room from 1:30-3 PM. We will be announcing our annual volunteer awards and a provide our leadership's forward looking vision. Please join us!

Spring Fling

Come Hear about FDA's Relationship with Capitol Hill and the Inception of the Senate's Innovation Initiative

FDA has been a significant focus on Capitol Hill over the past year, and will continue to be with the upcoming PDUFA reauthorization. Come hear from the staff at the eye of the storm who will explain how FDA interacts with Capitol Hill and also how the Senate Innovation Initiative got off the ground.

Speakers: Wade Ackerman, Senior FDA Counsel, Senate HELP Committee; Kalah Auchincloss, FDA Deputy Chief of Staff.

Who: FDAAA Members, Associate Members & Guests

Where: Novo Nordisk Offices; 920 Massachusetts Ave NW, Suite 500, Washington, DC 20001

When: Monday, June 13th, 11:45 AM-1:30 PM

What: Catered Sandwich Lunch

Cost: $20 members; $45 non-members; Please Pay Pal if possible on FDAAA website. Please RSVP to Rachel Turow (RCTU@novonordisk.com).

Speakers Lunch

FDA Seeking "Objective" Reviewers for Grant Funding

FDA's Office of Partnerships (HHS/FDA/ORA/OP) is actively looking for Scientific, Regulatory, and Public Health professionals to serve on Objective Review Board (ORB) panels to review, score, and comment on grant applications for the 2016 funding award cycle. Objective Review Boards are a mandatory process to award funding for FDA's grant and cooperative agreement programs. Prior service and experience on ORB panels is not required. Please note that these activities are an agency priority, as several of the grant and cooperative agreement programs are Congressionally-mandated.

To volunteer, please email your request with a current resume and the completed ORB Reviewer Questionnaire to Graham N. Giesen at op.reviewers@fda.hhs.gov.

Details on who can serve as an objective reviewer, how to apply and other information, including the Questionnaire, are available here.

FDAAA Members Are Updated on Combination Products

A great combination: Barr Weiner, Associate Director for Policy, OCP (left) and Thinh Nguyen, Director, Office of Combination Products (OCP)(right), offered FDAAA members insight into the increasingly important future of combination products and the collaborative cross-center efforts the FDA is implementing to meet future opportunities. The lunch took place at Mrs. K's Toll House in Silver Spring.

Combination drugs/devices/diagnostic products are becoming increasingly more common. They enable patients to be treated and diagnosed with multiple products that are designed and approved to be used together.

Thirty FDAAA members joined Thinh Nguyen, Director, Office of Combination Products (OCP), and Barr Weiner, Associate Director for Policy, OCP, for a lively luncheon discussion on April 8 about FDA's latest initiative in reviewing combination products.

Thinh and Barr gave a brief overview of OCP's current activities and then discussed some of the major "hot topics" in combination products, including the formation of a new combination products policy council, implementing "lean process" mapping, improved reviewer training, and forthcoming guidances and regulations.

Thinh and Barr were extremely generous with their time and willingness to engage. Their participation underscores the ongoing close relationship between FDA and FDAAA.

FDA Alumni Advisor Program a Big Success

The FDA Alumni Advisor Program Pilot ended on March 18, 2016 after a 9 month run which showed that the program met its objectives and was successful in bringing back retirees to mentor current employees. Plans are underway to turn it into a formal program in the fall of 2016.

More...

FDAAA Contributes to WHO Guideline on Good Regulatory Review of Practices

By Florence Houn, MD

In 2015 World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations published its forty-ninth report, Annex 9, Good Review Practices: Guidelines for National and Regional Regulatory Authorities.

http://apps.who.int/medicinedocs/documents/s21902en/s21902en.pdf

This remarkable document contains the distilled wisdom of many regulators, experts, and the FDA Alumni Association (FDAAA). It is a simple primer for consideration by regulatory health authorities regarding the principles of good review practices (GRevP); management of the review, communications before, during and after review; review personnel; and the conduct of regulatory reviews of medical product applications.

The objective of the document is to provide high-level guidance on the principles and processes of good review practice (GRevP) for use across a range of regulatory authority (RA) maturities. It is not intended to provide detailed instruction on how to conduct a scientific review.

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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.

More...

Links to Recent FDAAA Events and Announcements

Recent FDAAA Events

  • FDAAA Members Are Updated on Combination Products (04/012/16)
  • FDA Alumni Advisor Program a Big Success (03/25/16)
  • FDAAA Contributes to WHO Guideline on Good Regulatory Review of Practices (02/20/16)
  • 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