Orthobiologics Strategy: FDA Issues New Warning about Sales of Unapproved Products

FDA’s enforcement discretion for Human Cell and Tissue Products ended in May. As some companies have taken a wait-and-see approach to regulatory strategy, FDA doubled down on its enforcement commitment.

Despite a 10% contraction of the overall 2020 orthopedic market, directly attributable to the COVID-19 pandemic, the orthobiologic product...

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Scott Bruder ,M.D., founded the Bruder Consulting and Venture Group in 2015 after 25 years in the industrial sector, serving in the C-suites of Stryker, BD and Johnson & Johnson. In addition to his tenure throughout the industry, Dr. Bruder has maintained an active academic presence, serving as an Adjunct Professor of Biomedical Engineering at Case Western Reserve University since 2011, after 13 years as adjunct faculty in the Department of Orthopaedic Surgery. Currently, he also serves on the Board of Directors of both publicly-held and private equity-backed medical device companies.

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