Yes, an emergency investigational new drug (eIND) can include pediatrics, particularly for critically ill children who have no other satisfactory treatment options.
The FDA has a mechanism for expanded access that allows a physician to use an unapproved drug to treat a single patient in an emergency situation, and this process is used for children.
Pediatric applications of eIND are supported by research initiatives and can provide crucial treatment and data for rare diseases.
From Google:
* Sarcoma is a type of cancer that develops in bone or soft tissues, such as muscle, fat, nerves, deep skin tissues, and fibrous tissues.
It is a relatively common cancer among children, accounting for about 15% of all pediatric cancers.
___
Dr. J mentioned the Sarcoma success in the Rx video. Sarcoma included in our eIND is a very smart way to include a rare disease.
About 2k US Sarcoma cases yearly & is more aggressive than even Glioblastoma
Maybe the HNW individual, unfortunately, lost a child or young kid to a Sarcoma type??
The FDA has a mechanism for expanded access that allows a physician to use an unapproved drug to treat a single patient in an emergency situation, and this process is used for children.
Pediatric applications of eIND are supported by research initiatives and can provide crucial treatment and data for rare diseases.
From Google:
* Sarcoma is a type of cancer that develops in bone or soft tissues, such as muscle, fat, nerves, deep skin tissues, and fibrous tissues.
It is a relatively common cancer among children, accounting for about 15% of all pediatric cancers.
___
Dr. J mentioned the Sarcoma success in the Rx video. Sarcoma included in our eIND is a very smart way to include a rare disease.
About 2k US Sarcoma cases yearly & is more aggressive than even Glioblastoma
Maybe the HNW individual, unfortunately, lost a child or young kid to a Sarcoma type??
9
