Mar 272023
FDA Offers New Clinical Trial Guidance for Oncology Accelerated Approval
FDA details its view of the “limitations” of single-arm trials in oncology drug development and invites comment on its favored approach going forward. Becky Wood, Emily Marden, and Julea Lipiz explain.
Mar 152023
A Challenging Regulatory Environment Means More Care Needed with FDA Submissions
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.
