Expanded Access Q
Key Contact Information. 1. During Normal Business Hours (8 a.m. - 4:30 p.m. ET, weekdays). For emergency requests and specific questions during ...
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 ...
For more information on expanded access to investigational medical devices, you can visit: ... – Questions and Answers: http://www.fda.gov/downloads/drugs ...
FDA Expanded Access Program | OSF HealthCare
For questions, contact the FDA directly via the FDA Expanded Access Contact Information webpage. Clinical Research.
Overview of FDA's Expanded Access Program for Investigational ...
Keywords: expanded access, investigational new drug, single patient expanded access ... Expanded Access to Investigational Drugs for Treatment Use—questions and ...
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 / Compassionate Use - WCG
... expanded access review — there is no additional burden on the patient. For questions about submitting single-patient expanded access requests, please ...
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 ...
3014-502 - Expanded Access, Including Emergency Use of ...
Expanded access use of a drug, biologic or medical device is not research. NIH Investigators may not perform research interventions or collect or analyze data ...
Expanded Access and Right to Try: Access to Investigational Drugs
Source: FFDCA §§561 & 561B, 21 C.F.R. §312.305, FDA, “Expanded Access to Investigational Drugs for. Treatment Use—Questions and Answers,” ...
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, ...
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 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.
Individual Patient Expanded Access Investigational Drugs and ...
Expanded access is a potential pathway for patients with a serious or immediately life-threatening disease or condition to gain access to an investigational ...
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 ...
Working Group on Compassionate Use & Preapproval Access ...
How can I get access to an investigational agent? What are some patient resources? Questions About Expanded Access. What is an expanded access program (EAP)? ...
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 ...
What is an investigational therapy?
Q: What is the difference between expanded access and right-to-try? A: Both allow patients to apply for access to investigational therapies outside of clinical ...
Expanded Access - UC Davis IRB
Expanded Access, occasionally referred to as “compassionate use”, is a potential pathway for a patient with an immediately life-threatening condition or ...
Expanded Access to Unapproved Drugs, Biologics, or Devices
Expanded access allows for the use of unapproved drugs and biologics outside of a clinical trial for patients with serious diseases or conditions.