Senate counterpart to 21st Century Cures bill is struggling -

October 25, 2015. Politico. The Senate’s companion effort to the House-passed 21st Century Cures is struggling to navigate a dramatically different political reality than the one that helped rocket the medical innovation bill through the lower chamber over the summer.

Approved but not proven: what’s up with FDA, cancer drugs? -

October 22, 2015. Medscape Medical News. In approving new cancer drugs, the US Food and Drug Administration (FDA) is now heavily relying on surrogate markers of effectiveness, such as tumor shrinkage, instead of proof that an agent improves survival, according to a new analysis.

Comments of Members of the Patient, Consumer, and Public Health Coalition on “Testicular Toxicity: Evaluation During Drug Development – Guidance for Industry” -

Comments of Members of the Patient, Consumer, and Public Health Coalition on “Testicular Toxicity: Evaluation During Drug Development – Guidance for Industry” [Docket No. FDA-2015-D-2306-0001] We appreciate the opportunity to provide feedback to the FDA on the evaluation of testicular toxicity during drug development. The recommendations in the draft guidance are very important and we […]