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HBO and The Ringer's Bill Simmons hosts the most downloaded sports podcast of all time, with a rotating crew of celebrities, athletes, and media staples, as well as mainstays like Cousin Sal, Joe House, and a slew of other friends and family members who always happen to be suspiciously available.
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In this episode of RCA Radio, host Brandon Miller sits down with Jessica Schafersman, a design and development expert at RCA®, to break down the increasingly complex world of combination products—those that blend drugs, devices, or biologics. Jessica shares insights on why these products are uniquely challenging, the regulatory expectations companies must meet, and how the FDA guidance that is intended to make the submission process streamlined. From design controls and quality system integration to the importance of human factors validation and international considerations, this episode is packed with practical advice for any company entering or expanding in the combination product space.
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