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The FDAAA's New Website Recipient of the Frances O. Kelsey Award for Courage and Excellence in Protecting the Public Health The FDAAA’s New Website (Still at www.fdaaa.org ) We are so pleased to unveil our new website. Not only is this modernized website more attractive and easier to follow, it has great new features such as members-only access to a growing collection of FDA- related information, a skills inventory, and the ability to chat with other members behind a secure firewall. This website will take us into a new era when FDAAA does even more to support your ongoing enrichment, connection to each other and to FDA, and your ability to locate resources, colleagues, friends, and experts. The FDA Alumni Association is the official global network of former and current FDA employees, connecting and supporting alumni, the Agency, and the public health community. Please be active in FDAAA and help us to make a difference. In speaking about FDAAA, then-Commissioner Ned Sharpless recently reminded us of a key quote from Margaret Mead: “Never doubt that a small group of thoughtful, committed citizens can change the world; indeed, it’s the only thing that ever has.” Members are encouraged to visit the Newsletter - Updates for the latest edition of the Newsletter, July 2020. Deb Autor, Chair Board of Directors FDA ALUMNI ASSOCIATION SAVE THE DATE…for our first FDA Alumni Association VIRTUAL Speaker Series Event! We are thrilled to have Dr. Luciana Borio (former Director for Medical and Biodefense Preparedness Policy for the White House National Security Council and former Acting Chief Scientist and Assistant Commissioner for Counterterrorism and Emerging Threats at FDA ) as our guest speaker on COVID-19 issues. This virtual event will be held via Zoom on Wednesday, August 5 at 2:00 pm Eastern. Please be on the lookout for the official invitation to this event—coming soon! Lisa Barclay, Chair Activities Committee FDAAA F. Alan Andersen, PhD Newsletter – Update July, 2020 F. Alan Andersen, PhD FDAAA Past President Re-Naming the FDAAA Newsletter - Update Following is a bit about Alan and some of his many contributions to the FDAAA. F. ALAN ANDERSEN, PhD is a Senior Consultant at the EAS Consulting Group, LLC. Dr. Andersen received his BS from Muhlenberg College and his MS and PhD from Penn State. In 2013, he retired as the Director of the Cosmetic Ingredient Review, where he led that group’s mission to thoroughly review and assess the safety of ingredients used in cosmetics in an open, unbiased, and expert manner. Prior to joining CIR in 1993, Dr. Andersen was Acting Director, Office of Device Evaluation, and Director, Office of Science and Technology, at the Food and Drug Administration’s Center for Devices and Radiological Health. In his 22 years at FDA, he led efforts to deal with such diverse issues as tampons and toxic shock syndrome, sunlamp safety, laser safety and the evaluation of silicone breast implants. He has received the Public Health Service Superior Service Award, the FDA Award of Merit, Employees EEO Recognition Award, and the Sigma Xi Award of Recognition. He has received the FDA’s Distinguished Alumni Award and was made a Penn State Alumni Fellow in 2011. More recently, he received the Food and Drug Law Institute Distinguished Service and Leadership Award and the FDA Alumni Association (FDAAA) Founders Award. He is a charter member of the FDAAA. At the FDAAA, he has served as Chair of the Member Services Committee, Treasurer, Board of Directors member, and President. He currently serves on the Communications Committee. It is fitting that the association recognize Alan’s contributions by renaming the Newsletter – Updates to recognize his support over many years. Alan’s hard work is a testament to his support of the association and it is a pleasure to honor him this way. Alan, thank you for all you have done, “Serving Those Who Have Served”. This is a well-deserved recognition. Deb Autor, Chair BoD, the FDAAA Executive Committee, and Richard Baldwin, Chair Communications Committee Swan Song This will be the last FDAAA Update that I will pen, or whatever the correct verb is to encompass all the computer stuff that goes with putting together these newsletters. I have been doing the newsletter for a lot of years now (15+) and it is time for some new blood. Fredda Shere-Valenti and Barbara Cassens will take over the job. Fredda brings her long experience with the FDAAA to the table and you could say without fear of contradiction that she knows how to tell it like it is! And, in Barbara Cassens, we will have an associate member working on the information that the FDAAA is providing to its members. As the expression goes, what is not to like? Fredda Shere-Valenti was in the ORA organization for 25 years. Fredda held various positions supporting in the New York District Office and the New York Regional Laboratory. In ORA HQ Fredda served in the Office of Regional Operations, developing field compliance programs with Centers and assisting the other divisions' activities. In 1987, she transferred to the Division of Field Science, publishing the Laboratory Information Bulletin (LIB), maintaining the latex products database, and developing the microbiological chapter for the Laboratory Procedures Manual. In 1989 Fredda rose to a consumer safety officer in the Division of Import Operations Policy. Fredda transferred in 2002 to CVM and worked with BIMO general programs, eventually retiring from FDA. Barbara Cassens is the Director for the Office of Partnerships (OP). In her role as the Director of OP, she is responsible for the oversight, strategic planning, collaboration and integration with our federal, state, and local, partners, for manufactured human and animal food safety standards. Richard Baldwin, Chair of the Communications Committee, will serve as a backup to Fredda and Barbara, should the need arise. When you have information for the Newsletter – Updates please send them to [email protected] for forwarding to Fredda & Barbara. In the near future we will have a separate [email protected] e-mail, specifically to you to submit send items for the Newsletter. I want all of you to know that I have appreciated the opportunity to be involved with the FDAAA. I knew the folks working in the CDRH family from the time when I worked there. I got to know others across the rest of the Agency working on peer-review promotions for regulatory scientists and still more when I headed the independent Cosmetic Ingredient Review. But it wasn’t until my FDAAA involvement that I had the chance to get to know and interact with individuals who had spent their careers at FDA working in areas totally foreign to me – and that was and is truly wonderful, IMHO. I encourage each of you to take advantage of the opportunity for every face-to-face interaction (once social distancing practices are lifted or relaxed…) that FDAAA is able to provide, especially those from parts of FDA with which you were not involved, and keep reading the FDAAA Updates-Newsletter if you cannot be there in person. I will continue to be involved with the Communications Committee and help as I can as the FDAAA continues to move forward. Feel free to send us anything you think newsworthy at [email protected] and we will get it to the membership! New Members Associate members Welcome to new FDAAA associate members Kimberly Bailey, Mark Richard Baldwin, Steven Herbert Chasin, PhD, Jianxiong (George) Chu Kimberly has been with ORA since 1992 and is currently doing administrative management in Detroit. Mark has been with CDRH since 1995 and works as an IT specialist. Steven has been at CDRH since 1991 and currently serves as Associate Director for Professional Development in the Office of Regulatory Programs in the Office of Product Evaluation and Quality. George has been with FDA since 2003 and is a supervisory mathematical statistician in CDRH/Office of Product Evaluation and Quality/Office of Clinical Evidence and Analysis/Division of Clinical Evidence and Analysis 2 (Biostatistics). He serves as Assistant Division Director Biostatistics Team 7. Alumni members Welcome to new FDAAA alumni members Tanvir K. Bell, MD, Marsha B. Henderson, Gary G. Lloyd and Jamie C. Wilkins, PharmD. Tanvir worked as a medical officer in CDER for just over 4 years and she is now at Astra Zeneca serving as Global Clinical Programme Lead, Respiratory and Immunology, Research and Development. Prior to joining FDA, she was spent almost 10 years as an Associate Professor of Medicine at the University of Texas Health Science Center at Houston (UTHealth). Marsha served as FDA's Assistant Commissioner for Women's Health in the Office of the Commissioner until her retirement in 2019. She has been profiled as a nationally recognized innovative leader and change agent for the health of women and their families. Gary worked in ORA from 1962 to 1994 in the Newark District as a compliance officer. Just think of the stories he could tell about field work in FDA during those 32 years! Thank you for your service, Gary. Jamie worked at CDER in the Office of Surveillance and Epidemiology for over 9 years. When she left FDA, she was the Deputy Director in the Division of Risk Management. That Division develops and oversees REMS programs for approved drug and biologic products. She is now Director, Risk Management Products Lead in the Center of Excellence for Risk Management -Worldwide Safety at Pfizer. Opportunites 1. The Embassy of Denmark is seeking former FDA regulatory experts. The Danish Embassy, located in Washington, DC, regularly receives requests from companies in Denmark requiring regulatory advice that fall within the scope and authority of the FDA and its centers.
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