Posts in Medical Research.
CDC Updates Guidance on Opioid Prescriptions

In a shift from prior policy, the Centers for Disease Control and Prevention (CDC) proposed on February 22, 2022, new guidelines for prescribing opioid painkillers. The new guidance largely avoids figures on dosage strength and length of prescription and warns against abruptly or rapidly discontinuing pain pills for chronic pain patients. It directs physicians to individualize the process and use their best judgement in determining whether to prescribe opioids, and when they do, to start with the lowest effective dosage. The proposed guidelines encourage physicians to weigh ...

FDA Policy for Mobile Medical Applications

The start-up segment of our healthcare regulatory practice is focused on companies bringing digital health tools to market. As part of the efforts of the U.S. Food and Drug Administration (“FDA” or the “agency”) to clarify its regulatory stance on digital health tools, the agency released a revised guidance in 2019 entitled, Policy for Device Software Functions and Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff (the “Guidance”) ...

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