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 The recommendations in the draft guidance are very important and we […]

House overwhelmingly passes bill to speed FDA drug approvals -

The bill’s laundry list of provisions that tweak the process for approving new drugs or devices have raised significant concern from industry watchdogs and physicians who say the legislation is aimed more at helping drug and device companies than patients.

Diversity in clinical trials -

We Need Better Clinical Trials Our president explained to reporters why drugs have to be tested on all kinds of people to know who they work for and who can be harmed by them. Cancer patients deserve studies that include women and men, people under and over 65, and all major racial/ethnic groups.   FDA […]