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Vaccinations Regulatory Requirements Clinical Trials

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

Fenwick & West LLP on

As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Cozen O'Connor

HHS Advocates Mandated Placebo-Controlled Trials for New Vaccines: Implications for Clinical and Regulatory Practice

Cozen O'Connor on

The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more

Haug Partners LLP

Understanding the FDA’s Medical Products Clinical Trial Guidance amidst COVID-19

Haug Partners LLP on

Conducting medical product clinical trials during the COVID-19 public health emergency presents unprecedented challenges. In light of the challenges presented by COVID-19, the Food and Drug Administration (FDA) issued...more

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