Wednesday, August 12, 2020 1:09:52 PM
Sometimes called “compassionate use”, expanded access 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 no comparable or satisfactory alternative therapy options are available.
Expanded access may be appropriate when all the following apply:
Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition.
There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.
Patient enrollment in a clinical trial is not possible.
Potential patient benefit justifies the potential risks of treatment.
Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication.
No other drug is available in the market than Aviptadil,thats why it got Expanded Access status IMO.
Kona Gold Beverage, Inc. Updates Multi-Million Dollar Merger and Posts Over $1.2 Million in Q3 Revenues • KGKG • Nov 15, 2024 10:36 AM
HealthLynked Corp. Announces Third Quarter and Year-to-Date 2024 Results with Strategic Restructuring, Third-Party Debt Repayment, and Core Technology Focus • HLYK • Nov 15, 2024 8:00 AM
Alliance Creative Group (ACGX) Releases Q3 2024 Financial and Disclosure Report with an increase of over 100% in Net Income for 1st 9 months of 2024 vs 2023 • ACGX • Nov 14, 2024 8:30 AM
Unitronix Corp. Publishes Its Cryptocurrency Portfolio Strategy • UTRX • Nov 14, 2024 8:05 AM
Avant Technologies and Ainnova Tech Form Joint Venture to Advance Early Disease Detection Using Artificial Intelligence • AVAI • Nov 12, 2024 9:00 AM
Swifty Global Announces Launch of Swifty Sports IE, Expanding Sports Betting and Casino Services in the Irish Market • DRCR • Nov 12, 2024 9:00 AM