Legal Minute: Decoding the FDA's prescription drug use related software guidance

FDA Issues Crucial Guidance on Prescription Drug Software! Darshan Kulkarni delves into the FDA's recent guidance on prescription drug-related software. The discussion revolves around three key considerations:1. software functions, 2. end-user output, and 3. regulatory guidelines. Notably, the FDA emphasizes distinguishing between functions relying on direct device data transfer and those that don't. The document also outlines the significance of characterizing software ou...

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Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm -  Helping regulators see your business the way you do. We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.