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The article focuses on the Accelerated Approval Program for cancer drugs and the need to strike the right balance between expediting drug approvals based on surrogate measures and ensuring clinical benefits are confirmed in subsequent trials. Topics include the challenges and issues with the current program, proposed changes to the program, and the importance of safeguarding patient interests while accelerating drug development.

The article discusses the potential impact of Medicare price negotiations on cancer drug launches. It mentions that the Inflation Reduction Act (IRA) could lead to delays in the release of new cancer drugs, especially those with limited indications.

The article emphasize the crucial role of laboratory-developed tests in patient care, particularly in academic medical centers and caution against restricting beneficial tests. They advocate for a balanced regulatory approach, acknowledging the need for improved safety and effectiveness while ensuring continued access to essential testing.

The article reports that Health law is slow-moving accretive, but it also shapes the landscape of health care delivery in powerful ways. Since implementation of the law requires democratic deliberation, administrative oversight, and judicial enforcement, health law is often a lagging indicator of the norms of health care practice.

The article presents the discussion on Food and Drug Administration (FDA) facing a regulatory decision. Topics include offering insight to agency leaders facing difficult decisions for approving a drug for marketing or permitting a drug to remain on the market; and consisting of a conclusory sentence stating the application not raising important safety or efficacy issues.

The article reports that Despite medicine's long-standing reputation as a largely self-regulated profession, U.S. medicine in fact has a multifaceted and significant relationship with the law. Medical evidence and physicians themselves may directly influence legal decisions and trends, but more pervasively, statutes, regulations, court rulings, and requirements imposed by multiple levels of government profoundly shape U.S. medical practice.

The article focuses on the eroding judicial deference to the Food and Drug Association (FDA) and its consequences for public health. Topics include FDA has operated with deference from courts enshrined by the Supreme Court's landmark case Chevron U.S.A. v. Natural Resources Defense Council; and decisions of the Supreme Court regarding the Environmental Protection Agency and the Occupational Safety and Health Administration (OSHA) will have sweeping implications for public health agencies.

The article reports that Gene therapies aim to ameliorate or cure disease by altering part of the patient's genome by replacing, deleting, or inserting genetic material Gene therapies are associated with exceptionally high costs, which can impede patient access and strain healthcare budgets. It mentions various treatments that have been approved by Food and Drug Administration, including voretigene neparvovec (Luxturna) for treating retinal dystrophy and onasemnogene abeparvovec (Zolgensma).

The article reports that legislation permitting the U.S. government to negotiate Medicare drug prices has been weakened after pushback from the pharmaceutical industry. Topics include government's costs for filling prescriptions in federal programs; and medications by means of the National Institutes of Health (NIH) to fund biomedical research.

The article focuses on Revisiting the Food and Drug Administration (FDA) Approval of Aducanumab. Topics discussed include the Food and Drug Administration (FDA) granted accelerated approval to aducanumab (Aduhelm) for treatment of Alzheimer's disease; and the FDA made a late-stage decision to grant approval on the basis of aducanumab's ability to lower levels of beta-amyloid observable on positron-emission tomographic brain imaging.