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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 ...
This advisory committee has held 7 meetings since 2017 and has provided recommendations on complex issues, including patient engagement in clinical trial design and conduct, use of patient-generated health data in post-market surveillance, communications about medical devices, such as communications regarding cybersecurity vulnerabilities, AR ...
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 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 ...
Once a drug receives fast track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.
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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.