On January 16, 2018, the FDA announced that the Agency will be delaying implementation of parts of its "intended use" rule due to concerns raised by the industry.
Dr. Mary Richardson, iuvo's Chief Scientific Officer, was honored Wednesday evening, January 17, 2018 at a reception with the other finalists for the 2018 ATHENA Awards.
The ATHENA Award is presented by the Rochester Chamber of Commerce and honors professional women leaders who strive toward the highest levels of personal and professional accomplishments, devote time to their community, and forge paths of leadership for other women.
The reception was hosted at Constellation Brands in Victor, New York, and the winner will be announced on January 25, 2018 at a dinner at the Joseph A. Floreano Rochester Riverside Convention Center.
Good luck, Mary! We're all pulling for you!
There's frequently a flurry of FDA announcement near the end of the year, and this year was no exception. We wanted to highlight a couple of the more pertinent ones that may be of interest to our customers. The summaries below link to some of the more interesting guidance documents recently released.
On December 5, 2017, the FDA issued the final version of its guidance document for 3D printed devices. The document "Technical Considerations for Additive Manufactured Medical Devices - Guidance for Industry and Food and Drug Administration Staff" is meant to outline the agency's current thinking about devices made via these processes and will be supplemented by a webinar in January. More information on the webinar is available here.
The FDA has issued a number of guidance documents, primarily focused on the pre-submission process that medical device manufacturers use to improve the likelihood of success of a particular filing.
October 21, 2017 - Members of the iuvo toxicology team co-authored a paper in the October 2017 issue of Comparative Medicine, the international journal of the American Association for Laboratory Animal Science.
iuvo's CEO Ben Burton was the feature interview on Launch Team Inc's Beer & Blog Feature today, in an interview with Michele Nichols, Launch Team's President. The Beer & Blog format includes an interview combined with a beer tasting.
iuvo’s Director of Analytical Chemistry, Dr. Chris Houston, recently co-authored an article in the PDA Journal of Pharmaceutical Science and Technology entitled “Simulated Leaching (Migration) Study of a Model Container-Closure System Applicable to Parenteral and Ophthalmic Drug Products.”
The article is available at http://journal.pda.org/content/71/2/68.full.pdf+html