The specter of more drugs that cost upward of $84,000 hovered over a House subcommittee hearing Wednesday on whether current incentives are adequate to spur development of therapies for unmet medical needs such as Alzheimer's disease.

Shortages and the high cost of cancer drugs are putting treatment out of reach for many cancer patients in the U.S. In searching for solutions, experts at an Institute of Medicine National Cancer Policy Forum Monday looked at regulatory practices, reimbursement policies and societal attitudes that have contributed to a pricing structure that incentivizes innovation but potentially limits patient access.

The FDA finalized its rule listing the pathogens that qualify as targets for drugs being developed under the Generating Antibiotic Incentives Now (GAIN) provision of the FDA Safety and Innovation Act.

Instead of finalizing its draft guidance on human drug development under the Animal Rule, the FDA is revising the 6-year-old proposed recommendations.

The fiscal 2015 funding bill for the FDA that's now headed to the House floor has become a bully pulpit to keep the agency from backsliding on commitments ranging from accelerated approval and abuse deterrence to science-based, data-driven decision-making.

It's time to raise the bar for requiring makers of drugs and vaccines to create pregnancy exposure registries, the FDA was told Wednesday at a public meeting on postapproval evaluation of drug safety during pregnancy.

Unsuccessful in its first attempt to shut down the patent trolls threatening the livelihood of small businesses, the House is trying again.

Sending a clear signal to Washington, Louisiana is poised to become the second state to enact a law recognizing the right of terminally ill patients, who have run out of options, to try investigational drugs and devices.