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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 ...
In combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant ...
Breakthrough Therapy Designation is intended to expedite the development and review of therapeutic candidates that are under investigation for the treatment of serious or life-threatening conditions. Breakthrough Therapy Designation requires preliminary clinical evidence suggesting a candidate may provide substantial improvement over available ...
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. Fast track designation must be requested by the drug company.
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 ...
Last week, the New England Journal of Medicine published a letter from directors at the Food and Drug Administration clarifying some of the intricacies of its new breakthrough designation for ...
The U.S. FDA's Breakthrough Device Designation will speed this innovative technology into the U.S. market. I look forward to more interaction with the ground-breaking team at inbiome," said Professor Carl Wittwer. "We are honored to receive this designation from the FDA," said Dries Budding, CEO of inbiome.
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.