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 If your email address is outdated, or if you do not receive periodic FDAAA Updates from Alan Andersen, please let Karen Carson know.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.

Save the Date: WINTER COCKTAIL RECEPTION: December 6th

FDAAA has chosen to celebrate the dedication and smarts of FDA's former OCC heads and deputies at our annual end of the year cocktail reception!

  • What: "Hail to the Chief Counsels!" FDA Alumni Association Cocktail Reception
  • When: Tuesday, December 6, 2016; 6:00 PM - 8:00 PM
  • Where: Arnold & Porter, 601 Massachusetts Ave, NW. Parking is available in the building.
  • Who: FDA Alumni members, spouses, FDAAA Associate Members and special recruitment guests
  • RSVP: Contact Susan Cummins

Though we are still deciding which to serve: Dickinson Dionysus, Barton Hutt Bordeaux, Cooper Chianti, Scarlett Shiraz, Buc Sauvignon Blanc, Masoudi Malbec, Bradshaw Barolo or several others... we want to make sure you SAVE THE DATE!

FDA Celebrates 40th Anniversary of Medical Devices Amendments

It was 40 years ago, in 1976, when the Congress enacted and President Ford signed the Medical Device Amendments, which led to the creation of the Center for Medical Devices and Radiological Health.

On June 22, CDRH held a celebration to commemorate the occasion. CDRH now has 1,700 staffers compared to 180 in 1976.

Jeff Shuren, the CDRH director, spoke at the celebration and also posted a blog to mark the anniversary. In the blog, Jeff wrote: CDRH is "a vibrant family of individuals with a wide range of scientific, clinical, engineering, legal, and other expertise, who hail from a variety of backgrounds, and who are ready to tackle the latest scientific advancement."

Here is a link to the blog:

http://blogs.fda.gov/fdavoice/index.php/2016/06/fda-celebrates-the-40th-anniversary-of-the-medical-device-amendments/

Pictured here are former CDRHers and current FDAAA members: (left to right) Jim Benson, Bob Sauer, John Villforth and David Feigel. (Jim, Bob and John all were intimately involved in the founding of both CDRH and FDAAA, while Dave served later as CDRH director.)

FDAAA Honors Three Leaders

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.

Spring Fling!

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.

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.

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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