Expanded Access FAQ

Expanded Access to Investigational Drugs for Treatment Use - FDA

As a result, FDA is providing guidance in a question and answer format, addressing the most frequently asked questions. In a separate guidance, ...

Expanded Access to Investigational Drugs for Treatment Use - FDA

FDA received numerous questions concerning implementation of the regulatory requirements for expanded access. As a result, FDA issued the ...

Expanded Access FAQ

Expanded access, also known as "compassionate use", is the use of an investigational new drug (IND) or biologic to treat a patient with a serious or ...

Common Questions about Expanded Access Programs

EAP stands for Expanded Access Program (EAP) and is sometimes referred to as Compassionate Use Program or Expanded Access Protocol Program.

Treatment Use of Investigational Agent - Penn IRB

Expanded Access for More Than One Patient. If an investigator ... Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers ...

Working Group on Compassionate Use & Preapproval Access ...

Questions About Expanded Access. What is an expanded access program (EAP)?; How many patients has expanded access helped? Why not remove the FDA from the ...

Frequently Asked Questions - VICTR AIM

Expanded Access (also sometimes referred to as “Compassionate Use”) is FDA's program allowing for the use of an investigational new drug (IND) or biologic to ...

Expanded Access

Non-emergent Expanded Access to Investigational Drugs IMPORTANT: A single patient expanded access may take up to 30-days for FDA to perform a safety review.

Expanded Access to Unapproved Drugs or Biologics

Under FDA regulations (21 CFR 312.300), expanded access allows for the use of unapproved drugs and biologics outside of a clinical trial for patients with ...

Expanded Access to Investigational Drugs for Treatment Use ...

FDA is providing this guidance in a question-and-answer format, addressing the most recent frequently asked questions and sharing recommendations.

Questions to Ask About Group and Single-Patient Expanded Access ...

What is expanded access (EA) and when should we consider it? How do I find out if I can apply to gain access to these drugs? Are there specific eligibility ...

Expanded Access Guidance - UW Research

This webpage describes the IRB-related requirements and procedures for the mechanisms that allow expanded access to investigational drugs, devices, and ...

Expanded Access - UT Southwestern Medical Center

The Food and Drug Administration's (FDA) Expanded Access Program (EAP) provides provisions for the treatment of patients with medical products (drugs, ...

What is an investigational therapy?

Frequently Asked Questions. Right-to-Try and Expanded ... A: Under RTT, patients face significantly more risks than they do in the expanded access program.

Expanded Access Data Element Definitions - ClinicalTrials.gov

Patient registries may be single purpose or on-going data collection programs that address one or more questions. Expanded Access: An investigational drug ...

Expanded Access to IMPs: FDAs Questions & Answers

When finalized, the revised guidance "Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers" will replace the June ...

Expanded Access to Investigational Drugs for Treatment Use

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers: Guidance for Industry. Final. Issued by: Food and Drug ...

FDA: Expanded Access/Treatment Uses (including Emergency Use)

NOTE: If you are not collecting information for research, answer the HIPAA questions as appropriate. The HIPAA attestation and waiver document is not required ...

Expanded Access | RIO - Research & Innovation Office

For questions about and requests for emergency use and expanded access for drugs, biologics, devices or to get an emergency IND or IDE, contact FDA: Normal ...

For Patients and Caregivers | Expanded Access Navigator

For guidance on how to navigate the ClinicalTrials.gov website, refer to our ClinicalTrails.gov User Guide. Image. Physicians Guide. How do clinical trials ...