The National Cancer Institute (NCI) is considering the development of a specimen bank for tube and ovary tissues from women undergoing surgery for benign conditions, risk reduction and early stage cancer. Collecting tube and ovary tissues containing clinically unsuspected precursors or early stage cancer has been challenging, especially from women who are not at increased genetic risk, according to an NCI notice.
The FDA finalized a draft guidance released nearly a year ago about when sponsors of drugs with potential estrogenic, androgenic or thyroid (E, A or T) activity should submit an environmental assessment (EA) or a claim of categorical exclusion. The guidance also clarifies what information should be included in an exclusion claim. Since late cycle requests for additional environmental information could delay approval, sponsors should consult with the FDA early on about the information that may be needed to determine whether an EA or an exclusion claim would be required. Failure to submit an EA or exclusion claim for a drug with E, A or T activity could lead to the FDA refusing to file an application or denying approval.
The U.S. Department of Veterans Affairs said it is now able to fund care for all veterans with hepatitis C for fiscal year 2016, regardless of the stage of the patient's liver disease. The move follows increased funding from Congress, along with reduced drug prices. Since the beginning of 2014, more than 42,000 patients have been treated with the new antivirals.