加速审批政策，如快速通道、优先评审、加速审批和“突破性药物”等，旨在促进药物的开发和上市，以满足患者对新疗法的迫切需求。美国21世纪治愈法案（21st Century Cures Act）的提出，旨在进一步加速药物审批流程，这在理论上能够快速将创新药物推向市场，帮助患者。然而，这一政策引发了一系列争议和担忧。一...
今年夏天，美国政府又提交了“21世纪治愈法案”（21st Century Cures Act）旨在进一步推动药物审批加速。然...
dollars, as Diana Zuckerman and colleagues outline A controversial proposed law in the United States, the 21st Century Cures Act, is described by supporters as an innovative attempt to jump start the process of finding new cures for the thousands of diseases that currently lack effective treatments...
21st Century Cures Act November 25, 2022 Uncategorized Understanding test results can be challenging The 21st Century Cures Act is a new federal law that requires health care providers to give patients access to their health information without delay. This means you may see results from a test ...
Top 10 Provider Misconceptions About Cures Act Implementation As health systems are working toward compliance with the provider requirements of the 21st Century Cures Act, many are discovering that interpretation and application of the federal rules raise many questions and misconceptions. ...
With the 21st Century Cures Act (opens in a new window) and the provision for open notes, effective April 2021, it is more important than ever to be compliant with requests from patients reviewing their records. The Cures Act requires healthcare providers to improve how easily patients can ac...
The 21st Century Cures Act--Will It Take Us Back in Time? In May 2015, the 21st Century Cures Act was introduced in the U.S. House of Representatives, with the goal of promoting the development and speeding the approval of new drugs and devices.(1) Championed by the pharmaceutical, ...
Join Baker Donelson for an informative webinar discussing the 21st Century Cures Act and the significant impact it has on the electronic health information environment. The noteworthy changes relate to penalties for information blocking and interference with or discouraging of the free flow of electronic...
In May 2015, the 21st Century Cures Act was introduced in the U.S. House of Representatives, with the goal of promoting the development and speeding the approval of new drugs and devices.(1) Championed by the pharmaceutical, biotechnology, and device industries, the bill was approved unanimous...
21st Century Cures Actneglected diseasesEbolaZikaincentivesThe priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in tradiSantos Rutschman, AnaSocial Science Electronic Publishing...