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 If your email address is outdated, or if you do not receive periodic FDAAA Updates from Alan Andersen, please let Karen Carson know. (email@example.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.
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).
FDAAA has presented awards to three alumni who have made significant contributions to the organization. The three photos depict Awards Committee Chair and Board Director Marie Urban (in all three photos) presenting the Founders Award to FDAAA President Ed Steele (Chair Nancy Myers looking on), the Certificate of Appreciation to Member Service Committee Chair Karen Carson, and the Service Recognition Award to Fredda Shere-Valenti, who recently retired from FDA and who has been active in FDAAA since its inception.
Each year the FDAAA sponsors a Spring Fling which attracts not only members from the FDAAA but also the senior leadership of the FDA. This year's May 18 event was no exception. New FDA Commissioner Robert Califf spoke about the agency and his plans moving forward.
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 firstname.lastname@example.org.
Details on who can serve as an objective reviewer, how to apply and other information, including the Questionnaire, are available here.
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.
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.
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./p>
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.
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.
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).
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.
Recent FDAAA Events
- FDA Seeking "Objective" Reviewers for Grant Funding (04/19/16)
- Vacancy Announcements for Key Alumni Association Positions (12/18/15)
- 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)