Erleada Clinical Study Report Is First Release In Drug Review Transparency Pilot
Executive Summary
US FDA publishes 1,000+ page CSR for J&J's prostate cancer drug, and eight more products will follow. But how useful will the extra information be?
You may also be interested in...
Clinical Study Report Release Could Compromise Patient Privacy, Groups Say
US FDA's plan to post CSRs may also inadvertently release confidential commercial information, agency is warned by industry groups.
US FDA May Scrap Clinical Study Report Disclosure For New Drug Approvals
The pilot project former Commissioner Gottlieb championed found only one sponsor interested in participating.
Janssen’s Apalutamide First To Gain Approval Under International Work Sharing Program
The ACSS Consortium’s work-sharing pilot for new drugs has yielded its first twin approval, for Janssen’s prostate cancer treatment, apalutamide.