The FDA, in collaboration with the NIH’s National Center for Advancing Translational Sciences (NCATS), has launched a new data-sharing app called CURE ID. The app helps healthcare professionals explore successful ‘off-label’ uses (uses not described in the approved FDA label) of existing drugs to treat neglected infectious diseases.
Healthcare professionals may choose to prescribe a marketed drug for an unapproved use when they judge that the unapproved use is medically beneficial for a patient. This is a […]
Earlier this month, former FDA Commissioner, Scott Gottlieb, spoke about real-world evidence (RWE) at the Patient-Centered Oncology Care meeting, in Philadelphia, Pennsylvania, saying that the FDA has the money and the mandate from Congress to accelerate the use of RWE in the drug approval process.
RWE is defined as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than […]
A biopharma company developing a new drug for a rare form of cancer partnered with WEP Clinical to run an Expanded Access Program (EAP). Because the company’s drug is being developed to treat a rare condition, the clinical trial population is small. As such, the company wanted to be able to collect additional data from EAP patients to better understand patient’s quality of life and to gain additional insight on […]
A rare disease company developing a new drug for a lysosomal storage disorder partnered with WEP Clinical to run an Expanded Access Program (EAP). The drug was already being provided under various investigator-sponsored EAPs. When this company opened their blinded clinical trial, additional EAP requests were being received and the company needed a trusted partner to manage the EAP requests. This program served many purposes: 1) transition existing compassionate use […]