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The Breakthrough Devices Program [21] and Safer Technologies Program (STeP) [22] programs facilitate timely access to life-saving devices by expediting regulatory review. Devices granted a designation qualify for priority review and active engagement of senior management.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012.It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics.
A breakthrough therapy designation can be assigned to a drug if "it is a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition" and if the preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as ...
The FDA's breakthrough tag is given to certain medical devices that provide treatment or diagnosis of life-threatening conditions. The experimental device, known as Blindsight, "will enable even ...
Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need.
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Fee Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – standard review and priority review.
The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016 and then signed into law on December 13, 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health. [1]
Image source: The Motley Fool. Align Technology (NASDAQ: ALGN) Q4 2024 Earnings Call Feb 05, 2025, 4:30 p.m. ET. Contents: Prepared Remarks. Questions and Answers. Call Participants