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This cohort study assesses the validity of molecular targets and therapeutic benefits of US Food and Drug Administration (FDA)–approved genome-targeted cancer drugs based on the outcomes of their corresponding pivotal clinical trials.

This economic evaluation assesses how the efficiency frontier approach could align prices and clinical benefits of biologic medications for plaque psoriasis and estimates price reductions in the US vs 4 peer countries.

This cross-sectional study assesses the characteristics of patients with Duchenne muscular dystrophy receiving novel treatment in routine care compared with patients in clinical trials.

This cross-sectional study compares price data for ocrelizumab and rituximab to estimate the savings to Medicare and Medicaid if rituximab were used in the treatment of multiple sclerosis instead of the higher-priced ocrelizumab.

This cohort study uses commercial insurance claims to compare the incidence of first moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation and first pneumonia hospitalization among patients with COPD who started using inhalers with long-acting muscarinic antagonists and long-acting β-agonists (LABAs) vs inhalers containing inhaled corticosteroids and LABAs.

This cross-sectional study characterizes state-level variation in the use of targeted therapies among Medicaid patients with metastatic non–small cell lung cancer and describes factors associated with this variation.

This cross-sectional study evaluates the variations in use of diabetes drugs with cardiovascular benefits among Medicaid patients.

This cohort study used the Drugs@FDA database to identify new drugs approved by the US Food and Drug Administration (FDA) and assess fulfillment of postmarket commitments and requirements.

This Special Communication examines the role of the Park doctrine in relation to other tools the Department of Justice has against misconduct by drug and medical device companies.

This cohort study assesses the regulatory context, pivotal design characteristics, and postmarket requirements and commitments of novel drugs approved by the US Food and Drug Administration (FDA) in 2020 to characterize the state of evidence at the time of approval.

This cross-sectional study examines extrapolation of data for US Food and Drug Administration (FDA) drug approval based on disease severity, disease subtype, and concomitant medication use.

This Viewpoint reviews the history of over-the-counter rescue inhalers and outlines why they again should be made available to patients with asthma without prescription from a physician.

This cohort study uses data from a national claims database to investigate the association of concurrent administration of the influenza and zoster vaccines with influenza vaccine uptake the following year in patients older than 50 years.

This Special Communication reviews the development of laws and standards affecting the evaluation and oversight of medical devices by the US Food and Drug Administration (FDA) and the outcomes of this regulatory system from 1976 to 2020.

This cohort study investigates downstream public-sector support for the creation of new biologic drugs by examining their patent and drug development histories.

This cross-sectional study uses data from the US Food and Drug Administration (FDA) to review the postmarketing requirements and commitments attached to new vaccines approved for use in the past 15 years in the United States.

This Viewpoint discusses policies the Biden administration can enact to reduce costs, including benchmarking Medicare Part B drug payments to the lowest price paid in similar countries, preventing Part D plans from negotiating confidential rebates with manufacturers, and patent reform to promote generic drug use.

This Viewpoint reviews the enormous political and public pressures the FDA is likely to be under in fall 2020 to provide emergency authorization or approval of candidate COVID-19 vaccines, and urges adherence to existing science-based protocols for approval to ensure vaccine safety and acceptance and thus protect the public’s health.