Investigational Drug Access Taken To Task in Lawsuit Against FDA
نویسندگان
چکیده
منابع مشابه
Compassion vs Control: FDA Investigational-Drug Regulation
Victims of AIDS and other incurable diseases are denied access to potentially valuable experimental drugs by the U.S. Food and Drug Administration. Under the present law, no new drug or medical device can be sold until it has been approved as safe and effective" by the FDA. New-drug approval is an expensive process that routinely takes years to complete. Unapproved experimental products cannot ...
متن کاملUnderstanding FDA regulatory requirements for investigational new drug applications for sponsor-investigators.
Clinical investigators invoke a number of specific regulatory requirements if their study includes use of a pharmaceutical agent. Studies using a drug that has not been approved by the Food and Drug Administration (FDA) or for indications not in the approved labeling may require filing an Investigational New Drug (IND) application with the FDA. If a study meets specific regulatory exemption cri...
متن کاملDo Off-Label Drug Practices Argue Against FDA Efficacy
The Food, Drug and Cosmetics Act of 1938 with amendments in 1962 is inconsistent regarding FDA certification of a drug's efficacy. The act requires efficacy certification for the drug's initial (" on-label ") uses, but does not require certification before physicians may prescribe for subsequent (" off-label ") uses. Are there good reasons for this inconsistency? Using a sequential online surve...
متن کاملLeveraging exploratory investigational new drug studies to accelerate drug development.
In 2006, the U.S. Food and Drug Administration published its guide on exploratory investigational new drug (IND) studies with the goal of making the approach to early-stage, pilot clinical trials more flexible within the context of current regulations. The exploratory IND allows sponsors to initiate clinical trials of limited scale with reduced preclinical requirements. These studies may be imp...
متن کاملFDA's proposed regulations to expand access to investigational drugs for treatment use: the status quo in the guise of reform.
On December 14, 2006, the Food and Drug Administration (FDA) proposed two new regulations in the Federal Register amending current regulations governing expanded access to investigational drugs for treatment use and charging for investigational drugs. The proposals come at a time when FDA has found itself under new pressure to provide seriously ill patients with early access to investigational ...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: JNCI Journal of the National Cancer Institute
سال: 2003
ISSN: 0027-8874,1460-2105
DOI: 10.1093/jnci/95.24.1818