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FDA’s Shifting Stance on Public Disclosure of NDA and BLA Complete Response Letters – How Far Will It Go?

The US Food and Drug Administration has announced a renewed focus on a long-considered issue—whether FDA should release complete response letters (CRLs) issued to drug or biologic applicants. Specifically, on July 10, 2025...more

Current Developments in SEC Enforcement for Public Companies

The US Securities and Exchange Commission (SEC) continued its significant focus on public companies in 2022 with its enforcement and rulemaking programs. This heightened level of attention will likely continue as the SEC...more

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