FDA teleconference of Sept 13, 2012

 

Please read this excellent summary by Ms. Spotila of the teleconference call:

http://www.occupycfs.com/

Here is additional information about the FDA and NIH designations of serious or life-threatening condition:

 

[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2012]
[CITE: 21CFR312.81]

 

TITLE 21–FOOD AND DRUGS

CHAPTER I–FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

SUBCHAPTER D–DRUGS FOR HUMAN USE

 

 

PART 312 — INVESTIGATIONAL NEW DRUG APPLICATION

Subpart E–Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses

Sec. 312.81 Scope.
This section applies to new drug and biological products that are being studied for their safety and effectiveness in treating life-threatening or severely-debilitating diseases.

(a) For purposes of this section, the term “life-threatening” means:

(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and

(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival.

(b) For purposes of this section, the term “severely debilitating” means diseases or conditions that cause major irreversible morbidity.

(c) Sponsors are encouraged to consult with FDA on the applicability of these procedures to specific products.

[53 FR 41523, Oct. 21, 1988, as amended at 64 FR 401, Jan. 5, 1999]

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

 

 

 

 

Serious or life threatening disease or condition

Consistent with current FDA and ClinicalTrials.gov guidance, the NIH interprets “serious and life-threatening disease or condition” to mean: (1) diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and (2) diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival.

Any investigational drug that has received fast track designation by the FDA is considered a drug to treat a serious disease or condition.

The seriousness of a disease is a matter of judgment, but generally is based on such factors as survival, day-to-day functioning, and the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.  For further elaboration of the NIH’s interpretation of “serious or life threatening disease or condition”, please access the “Fact Sheet: Registration at ClinicalTrials.gov”.

 

 

 

http://grants.nih.gov/clinicaltrials_fdaaa/definitions.htm?print=yes&

A transcript of the call should be available by Sept 21st…    

 

 

 

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