Early/Expanded Access Types

Question 1

Expanded access protocol type when all of the following are met:
- Life-threatening or serious disease or condition
- No available alternative
- Controlled clinical trial
- Sponsor pursuing marketing approval
Requirements:
- Prior FDA approval of treatment IND
Takes Place:
- During clinical trial

Answer 1

Treatment Use

Question 2

Type of expanded access protocol when all of the following are met:
- Serious disease or condition
- No available alternative
Requirements:
- Prior FDA approval of IND supplement
Takes place:
- During clinical trial

Answer 2

Compassionate Use

Question 3

Type of expanded access protocol when all of the following are met:
- Life-threatening or serious disease or condition
- No available alternative
- No time to obtain FDA approval
Requires:
- Informed consent
- Report to IRB within 5 days of use
- Report to Sponsor
Takes place:
- Before or after initiation of clinical trial

Answer 3

Emergency Use

Question 4

Expanded access protocol type when all of the following are met:
- Public health need OR
- Preliminary evidence that the drug/device will be effective and there are no significant safety concerns
Requirements:
- Prior FDA approval of IND supplement
Takes Place:
- After completion of clinical trial

Answer 4

Continued Access