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FDA Announces Measure to Ease Patient Access to Investigational Drugs
In his blog post on FDAVoice, Peter Lurie MD, MPH, associate FDA commissioner for public health strategy and analysis, announced the introduction of a draft form and a draft guideline that can be used by a physician to request access to an experimental drug or biological product that is still under development.
Today, I had the pleasure of announcing an important measure intended to help streamline expanded access to investigational drugs. We heard concerns from patients and physicians that the process for gaining access to investigational drugs was too difficult, and pulled together a team to find a way to make that process simpler.
Today, we’re introducing a much simpler draft form for comment that, when finalized, should accelerate patient access to investigational drugs. We know what an important tool this will be for physicians who treat those patients with serious or immediately life-threatening diseases or conditions for which there are no comparable alternative treatments.
Link to the blog post on the FDA website: http://1.usa.gov/1BUwo6R
AI in Health Care: Balancing Governance, Innovation, and Trust
September 2nd 2025In this conversation with Reuben Daniel, associate vice president of artificial intelligence at UPMC Health Plan, we dive into how UPMC Health Plan builds trust with providers and members, discuss challenges of scaling AI effectively, and hear about concrete examples of AI's positive impact.
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Infertility Coverage Boosts ART Use and Pregnancy Success: Richard A. Brook, MS, MBA
August 26th 2025In this episode, Richard A. Brook, MS, MBA, discusses his study showing that infertility treatment coverage increases assisted reproductive technology (ART) use and improves pregnancy outcomes.
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Impact of Amivantamab-Lazertinib on EGFR, MET Resistance Alterations in NSCLC: Danny Nguyen, MD
September 15th 2025The combination of amivantamab and lazertinib in first-line non–small cell lung cancer (NSCLC) significantly reduces resistance mechanisms with implications for second-line treatment, said Danny Nguyen, MD, of City of Hope.
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