Lexology March 15, 2023
Sidley Austin LLP

In the first of a series on surviving the current financial and regulatory environment, Torrey Cope looks at how life sciences companies can reduce difficulties in getting new products approved by the U.S. Food and Drug Administration through effective written submissions.

Life sciences companies currently face numerous challenges when seeking approval for new drugs and biological products. This is partly because the science of new product development has generally become harder, with more companies pursuing therapies in areas that have long proved difficult to crack.

At the same time, the COVID-19 pandemic created lingering difficulties for both life sciences companies and the FDA. These include a reduction in the face-to-face interactions typically needed to reach alignment on thorny scientific and...

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