lunes, 9 de noviembre de 2026
FDA Investigating Serious Risk of Malignancy Linked to Zolgensma Gene Therapy (+++)
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-malignancy-linked-zolgensma-gene-therapy?utm_medium=email&utm_source=govdelivery
2026 Safety and Availability Communications
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/2026-safety-and-availability-communications
OTP Guidance Webinar: Potency Assurance for Cellular and Gene Therapy Products
December 10, 2026
Office of Therapeutic Products (OTP)
https://www.fda.gov/vaccines-blood-biologics/office-therapeutic-products-otp-events-meetings-and-workshops/otp-guidance-webinar-potency-assurance-cellular-and-gene-therapy-products-12102026?utm_medium=email&utm_source=govdelivery
domingo, 8 de noviembre de 2026
Medical Device Cybersecurity
https://www.fda.gov/medical-devices/medical-device-cybersecurity?utm_medium=email&utm_source=govdelivery
FDA Enhances Medical Device Cybersecurity Web Content
The U.S. Food and Drug Administration has updated its medical device cybersecurity webpages to make key information and resources easier to find and use.
What’s new:
Refreshed main page within the Medical Devices section, with improved visibility and usability.
Updated Guidance and FAQs with current information.
Two new webpages with resources on securing medical devices and information about cybersecurity collaborations.
Explore the updated content to find resources and information to help address cybersecurity considerations for medical devices.
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