WebExpanded Access, occasionally referred to as “compassionate use”, is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when there is no comparable or satisfactory alternative … WebJun 25, 2013 · The draft guidance is intended to provide information for industry, researchers, physicians, and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which went into effect on …
Expanded Access to Unapproved Drugs, Biologics, or Devices
WebExpanded Access Overview. 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 serious diseases or conditions when there is no satisfactory alternative therapy to treat the patient’s disease or condition. While expanded access is not ... WebThe Food and Drug Administration's Expanded Access Program allows for medical devices that are investigational (i.e., not FDA approved) to be used for treatment use outside of a clinical trial. Such use is not considered a clinical investigation however, FDA submission AND IRB review are necessary. The criteria for Expanded Access are largely ... how to select some rows in excel
Compassionate, expanded access and emergency use of …
WebAn expanded access IND goes into effect 30 days after FDA receives the IND or on earlier notification by FDA that the expanded access use may begin. (2) Protocols. With the following exceptions, expanded access use under a protocol submitted under an existing IND may begin as described in § 312.30(a). WebExpanded Access (EA) process was formalized through regulation in 1987 (drugs and biologics) - 1 and 1996 (devices) - 2, and EA was further codified in law in 1997 - 3. The EA program provides a process for patients to obtain authorization to use an investigational medical product for treatment use that has not been Web2024 FDA Guidance: IRB Concurrence. On October 3, 2024, the FDA issued new guidance regarding individual patient expanded access INDs. The new pathway still … how to select something in paint 3d