FDA regulation of Artificial Intelligence (AI) and Machine Learning (ML) follows a risk-based framework focused on safety and effectiveness throughout the product lifecycle. As of mid-2025, the FDA has authorized over 1,250 AI-enabled medical devices, with nearly 80% used in radiology .
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The pharmaceutical industry stands at a crossroads where regulatory expectations continue to evolve, patient safety remains paramount, and competitive pressures demand operational excellence. In this complex landscape, organizations …
The Raw Material Risks You Can’t Afford to Ignore: Ignoring raw material risks like unpredictable supply chains, political upheaval, or dwindling resource can seriously disrupt production, drive up costs, and weaken a company’s ability to bounce back.
You’ve heard the buzz, the big promises, the dystopian warnings. But what’s the real story? Let’s peel back the curtain and talk about the good, the bad, and the truly, unbelievably ugly parts of AI, with a little help from some of the smartest people
The journey to the GMP lab of the future is not without its obstacles. These challenges require careful planning, significant investment, and a willingness to embrace change at every level of the organization.