A watchdog group is once again calling on Health and Human Services (HHS) to withdraw a draft FDA guidance that provides best practices for distributing scientific and medical publications on new risk information for approved drugs and biologics.
One of the most notable new trends in advancing biomedical development is the rise of the patient voice. For that voice to be effective, science needs to turn patient stories into rigorous, useful data.
If precision medicine is to be the future of health care in the U.S., the FDA must stop dragging its feet on qualifying biomarkers necessary to develop targeted therapies and track disease advancement, according to a report released Wednesday by the Manhattan Institute for Policy Research.
Rather than offer up a buffet of ideas to streamline the development of new drugs, diagnostics and medical devices, Sen. Lamar Alexander (R-Tenn.) hopes to boil down the Senate response to the House 21st Century Cures Initiative to a few meaningful ways to reduce the cost and time involved in getting a new cure from discovery to the medicine cabinet.
While the FDA may have opened the biosimilar pipeline with its approval of Sandoz Inc.'s Zarxio Friday, a lot of heavy lifting has to be done before biosimilars are a viable market in the U.S.
