Erleada Clinical Study Report Is First Release In Drug Review Transparency Pilot
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?
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US FDA's plan to post CSRs may also inadvertently release confidential commercial information, agency is warned by industry groups.
The pilot project former Commissioner Gottlieb championed found only one sponsor interested in participating.
The ACSS Consortium’s work-sharing pilot for new drugs has yielded its first twin approval, for Janssen’s prostate cancer treatment, apalutamide.