|
- Breakthrough Devices Program - U. S. Food and Drug Administration
For questions about this document regarding CDRH-regulated devices, contact the Office of Clinical Evidence and Analysis (OCEA) at 301-796-5550 or BreakthroughDevicesProgram@fda hhs gov
- Breakthrough Seizure Guide - epilepsymichigan. org
Breakthrough seizures—those that occur after a period of seizure control—can be unsettling This guide offers evidence-based strategies to help individuals with epilepsy manage and prevent such episodes
- Good Review Practice: Management of Breakthrough Therapy . . .
It outlines CDER actions from the time a breakthrough therapy designation has been granted until a marketing application has been submitted
- Coding of Seizures and Epilepsy
Epileptic seizures range from clinically undetectable (“electrographic seizures”) to convulsions There are many paroxysmal behavioral spells that resemble epileptic seizures
- Breakthrough Annual Report FY24-Final-Digital-Update0210
Breakthrough is a faith-based organization that provides holistic, wraparound services in partnership with our community of Garfield Park Our programs are built upon a profoundly simple formula: people first
- Overview of CDRH’s Breakthrough Devices Program
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions
- GRIN Therapeutics Receives FDA Breakthrough Therapy . . .
NEW YORK, NY, February 25, 2025 – GRIN Therapeutics, Inc , a leader in the development of therapies to treat serious neurodevelopmental disorders, today announced that the U S Food and Drug Administration (FDA) granted Breakthrough Therapy designation to radiprodil, the company’s investigational, potent negative allosteric modulator
|
|
|