Toscano Consulting Group

The FDA has released draft guidance to enhance the credibility of artificial intelligence (AI) models in drug and biological product submissions. This initiative aims to ensure that AI-driven data on safety, effectiveness, and quality meet the agency's rigorous standards. Since 2016, there's been a significant rise in AI applications within drug development, underscoring the need for clear regulatory frameworks. The FDA's proposed risk-based approach emphasizes defining the model's context of use and assessing its credibility accordingly. Stakeholders are encouraged to engage with the FDA early in the development process to ensure compliance and foster innovation. For more details, read the full announcement: https://lnkd.in/ev8sgq7c

Wishing you a happy holiday season from all of us at the Toscano Consulting Group. 🎁

We were fortunate enough to attend and sponsor the Food and Drug Law Institute (FDLI) Enforcement, Litigation, and Compliance Conference last week in Washington, DC. This conference a wonderful opportunity to learn and network and our TCG team was able to connect in real life!

A comprehensive meta-analysis has revealed that GLP-1 receptor agonists, such as semaglutide (Ozempic, Wegovy), dulaglutide (Trulicity), and liraglutide (Victoza), significantly reduce the risk of kidney failure and cardiovascular events in individuals with type 2 diabetes, obesity, and chronic kidney disease (CKD). The study found a 16% reduction in kidney failure risk and a 14% decrease in major cardiovascular events compared to placebo. These findings suggest that GLP-1 receptor agonists play a crucial role in protecting both kidney and heart health in these populations.  https://lnkd.in/gDv_9ZvG

In one week our team will be at the Food and Drug Law Institute (FDLI) Enforcement, Litigation and Compliance Conference. Please let us know if you'll be joining us at the conference. We are looking forward to connecting with industry contacts and learning a lot. https://lnkd.in/gaJBXf8T

Wishing you and your families a warm and happy Thanksgiving from all of us at the Toscano Consulting Group.

The FDA has approved Kebilidi (eladocagene exuparvovec-tneq), the first gene therapy for aromatic L-amino acid decarboxylase (AADC) deficiency, a rare genetic disorder causing severe motor and cognitive impairments. Administered via neurosurgery, the therapy boosts dopamine production, crucial for movement and learning. Approval under the Accelerated Approval pathway highlights a significant step in addressing unmet needs for rare genetic conditions. Read more about this breakthrough here: https://lnkd.in/er5tacke

The FDA recently updated data on Breakthrough Device designations and marketing authorizations. Since the program's launch, it has granted 1,041 Breakthrough Device designations and authorized 128 devices for marketing as of September 30, 2024. This program is designed to provide patients and healthcare providers with faster access to innovative medical devices by accelerating development, assessment, and review processes. Through it, manufacturers receive guidance from FDA experts and prioritized reviews on regulatory submissions, helping streamline the path to market. https://lnkd.in/ebfg63fD #innovation #healthcare #medicaldevices #FDA

As artificial intelligence (AI) advances across healthcare, it’s crucial for regulatory frameworks to keep pace. The FDA has authorized nearly 1,000 AI-enabled medical devices, marking significant progress, but new approaches are needed to evaluate AI's unique challenges in clinical care and medical research. Strong FDA oversight will play a pivotal role in fostering safe, effective, and trustworthy AI in healthcare. Read the full article here: https://lnkd.in/eXtikgzb

MITRE’s recent white paper highlights crucial steps for managing cybersecurity risks in legacy medical devices. Key recommendations focus on lifecycle responsibility, vulnerability management, workforce training, and mutual aid to enhance resilience. This collaborative effort outlines practical resources and templates for effective risk management, aiming to bridge gaps for providers with limited resources. https://lnkd.in/gG6wv6_i