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FDA turns focus on biologics in spate of warning letters
The three letters point to an enforcement posture toward manufacturers marketing biologics derived from human placentas and umbilical cords.
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Wearable maker Whoop continues to push back against FDA warning
Dispute centers on whether wearable wellness kit should be classified as medical devices.
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GRIP Extra: US bank regulators scrap leveraged lending guidance, CFTC greenlights spot crypto products
Our in-brief roundup of notable stories from the last week.
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GRIP Extra: CME suffers 11-hour systems outage, US bank regulators ease key thresholds
Our in-brief roundup of notable stories from the last week.
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Understanding FDA cybersecurity requirements for medical devices and FCA enforcement
Key considerations for medical device manufacturers and how to prepare for a cybersecurity incident.
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Australia’s treasurer stops Cosette Pharmaceuticals’ $387.2m takeover bid of Mayne Pharma
The ups and downs of the proposed deal demonstrate the evolving landscape of compliance in the context of geopolitical tensions.
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Report to US lawmakers flags impact of China pharma on US drug supply chain
The report urges Congress to bolster US pharmaceutical supply-chain resilience and reduce dependence on China.
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GRIP Extra: Exec order targets state AI regulations, EU digital omnibus published
Our in-brief roundup of notable stories from the last week.