What does BTD mean in THERAPY
BTD stands for breakthrough therapy designation. This designation is conferred by the U.S. Food and Drug Administration (FDA) to new drugs or biologics that are intended to treat a serious or life-threatening disease or condition. It offers more rapid evaluation, development, and review of these therapies compared to standard processes.
BTD meaning in Therapy in Medical
BTD mostly used in an acronym Therapy in Category Medical that means Breakthrough therapy designation
Shorthand: BTD,
Full Form: Breakthrough therapy designation
For more information of "Breakthrough therapy designation", see the section below.
Essential Questions and Answers on Breakthrough therapy designation in "MEDICAL»THERAPY"
What is BTD?
BTD stands for “breakthrough therapy designationâ€. This designation is given by the FDA to drugs or biologics that are intended to treat serious or life-threatening diseases or conditions.
Who grants Breakthrough Therapy Designation?
The FDA grants Breakthrough Therapy Designation.
What benefits does Breakthrough Therapy Designation provide?
Breakthrough Therapy Designation provides more rapid evaluation, development, and review of therapies compared to standard processes. It also gives the drug sponsor access to early meetings with the FDA on trial design elements and eligibility criteria, as well as advice on biomarkers and other tools that might be used in clinical trials.
How is Breakthrough Therapy Status different from Fast Track Status?
Though both are processes that help expedite drug development and review for certain treatments, breakthrough therapy status places a greater emphasis on rapid clinical development and can provide additional benefits such as rolling reviews of different phases of trials within the same application.
Are all new drugs eligible for breakthrough status?
No, only those drugs intended for treating severe or life-threatening diseases are eligible for breakthrough status.
Final Words:
Breakthrough therapy designation can help accelerate the development process of promising new treatments for serious and life-threatening diseases and conditions by providing access to special programs, such as rolling reviews within an application, faster than usual by regulatory standards.
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