Dan White Chancellor

The FDA is signaling greater flexibility in approving certain new drugs based on a single adequate and well-controlled clinical trial, rather than the historical expectation of two pivotal studies.1-3 Under current law, the FDA has long retained discretion to approve drugs based on “substantial evidence” of effectiveness, which can be derived from one robust trial with confirmatory evidence, depending on context.¹ However, in practice, sponsors have frequently conducted two pivotal studies to...

DHL Group—capitalizing off the momentum garnered from the LAX cold storage project—is expanding its dedicated airfreight cold chain network, aimed at strengthening global logistics for temperature-sensitive pharmaceutical products, vaccines, and advanced therapies.