Steven Solomon’s Retirement; Communications on Foodborne Illness
Top-Line
Alliance Congratulates Dr. Steven Solomon, Director of CVM, On 32 Years of Service to FDA.
FDA Expands Communications on the Agency’s Response to Foodborne Illness.
ICYMI: Stories About FDA That We Read with Interest.
Alliance 2023 Dues Invoices to be Sent in Early November.
This week’s Analysis and Commentary summarizes the Alliance’s recent webinar on digital health and cyber security with Dr. Suzanne Schwartz, the Director of CDRH’s Office of Strategic Partnerships & Technology Innovation (OST).
Alliance Congratulates Dr. Steven Solomon, Director of CVM, On 32 Years of Service to FDA. This week, Dr. Solomon announced that he will be retiring at the end of the year. Dr. Solomon has been part of several Alliance webinars, most recently on “FDA’s One Health Initiative.” The transcript of that program can be found here.
Agri-Pulse published a review of Dr. Solomon’s career and quoted some of the many accolades that he has received. The Alliance adds its own: “Dr. Solomon has been the Alliance’s guide to understanding the special role and many responsibilities of CVM. We congratulate him on his career at FDA and the many accomplishments during his long service to the agency.”
FDA Expands Communications on the Agency’s Response to Foodborne Illness. As part of its efforts to improve communications on how FDA responds to foodborne illness, the agency has released a dialogue among agency leaders from 1/ the frontline response team, 2/ the group that receives and evaluates food complaints, and 3/ the inspection team in the Office of Regulatory Affairs. Also, FDA has released a video that illustrates how FDA works together with CDC and state agencies to identify and respond to foodborne illness. FDA’s newly updated landing page for foodborne illness also has information and links to other sources of information. Also recently updated is FDA’s description of its CORE Network, which identifies, evaluates, and responds to outbreaks of foodborne illness.
ICYMI: Stories About FDA That We Read with Interest. In addition to our advocacy for increased resources for FDA, the Alliance continuously pursues its other objective: educating policymakers and media about FDA’s mission and its growing responsibilities. We are highlighting a few of this week’s reports that discuss FDA’s role:
Regulatory Affairs published a lengthy story about Commissioner Califf’s remarks at a conference held this week by AdvaMed, which is an Alliance member. He touches upon diagnostics reform, hiring and implementation of the new user fee agreements, global harmonization, remote facility inspections and reforming regulatory oversight of food.
Regulatory Affairs also published a story covering CDRH Director Dr. Jeff Shuren’s wide-ranging remarks at the same AdvaMed conference. Among other things, he highlighted his concerns about medical device cybersecurity, the lack of laboratory-developed test (LDT) oversight and his “fears that without new authorities, digital health innovation may go elsewhere.”
For those interested in a deeper dive on some of Dr. Shuren’s comments, the week’s Analysis and Commentary has a summary of the Alliance’s recent webinar with Dr. Suzanne Schwartz, who leads digital health and cybersecurity within CDRH.
FDA Continues to Advance Medicines for Children. The agency updated its website on this topic with new information and articles.
Agency IQ published an analysis of FDA’s programs to support ‘complex’ and ‘innovative’ trial designs
Alliance 2023 Dues Invoices to be Sent in Early November. The Alliance will be sending out its 2023 invoices during the weeks of November 5 and 12. This allows members to pay from their 2022 budget if they prefer. Otherwise, dues are expected in the first quarter of next year. If you need to start sooner than November, contact Elisa and she will send you an invoice. Thanks to all for supporting the Alliance.