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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

SEC Focus on the Life Sciences Industry: What to Expect and How to Prepare

The life sciences sector remains a critical area of focus for the US Securities and Exchange Commission (SEC) under the current administration. Companies operating in the healthcare, pharmaceutical, biotechnology, and medical...more

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