If the manufacturer makes an
investigational drug available to an eligible patient, the manufacturer may not seek compensation from the patient in conformance with the Texas statute (Tex.
For patients seeking expanded access to
investigational drugs and biologics, the new rules make the process easier to understand.
Determining whether Congress should direct the FDA to reform its
investigational drug regulations is a policy judgment involving the balancing of competing interests.
The FDA anticipates that the rule should reduce the documentation created by drug manufacturers that produce in-house
investigational drugs, and, in some cases, should reduce the amount of component and product testing.
Study endpoints: The measures used to determine whether an
investigational drug works.
Under the proposed regulations, a sponsor could charge for expanded access to an
investigational drug if the sponsor: (1) complies with the applicable requirements for the type of use for which charging is requested; (2) provides justification that the amount to be charged reflects only those costs that are permitted to be recovered; and (3) obtains prior written authorisation from the FDA.
Of the 100
investigational drugs recognized in this special report, more than one-third target various forms of cancer.
World Courier operates the world's largest integrated company-owned network of GMP-compliant
investigational drug storage facilities in developing and strategic locations, with depots in Argentina, Australia, Brazil, Chile, China, Colombia, India, Mexico, PerA, Russia and South Africa.
Caution: In the United States, the Endeavor and Endeavor RESOLUTE drug-eluting Coronary Stents are investigational devices with an
investigational drug (zotarolimus) and are exclusively for clinical investigation.
Caution: In the United States, the Endeavor drug-eluting Coronary Stent is an investigational device with an
investigational drug (zotarolimus, ABT-578) and exclusively for clinical investigation.
Caution: The Endeavor Drug-Eluting Coronary Stent is an investigational device with an
investigational drug (ABT-578) and exclusively for clinical investigation in the United States.
PBI is specifically contracted to provide central laboratory support as well as specialty biomarker testing relating to the mechanism of action of an
investigational drug as part of a US-based phase I clinical trial.
