FDA Publishes Guidance on Investigational In Vitro Diagnostics
The guidance describes an optional streamlined submission process for use of an investigational in vitro diagnostic in a clinical trial for oncology therapies.
FDA published guidance on Oct. 9, 2019 describing an optional streamlined submission process for determining whether use of an investigational in vitro diagnostic (IVD) in a clinical trial for an oncology therapeutic is considered significant risk (SR), nonsignificant risk (NSR), or exempt from investigational device exemption (IDE) requirements. According to FDA, a sponsor may need to submit an IDE to either the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER) if the IVD in the trial is determined to be SR, in addition to submitting an investigational new drug application (IND) to the Center for Drug Evaluation and Research (CDER) or CBER. FDA states that using the streamlined process may reduce administrative burden on sponsors and FDA.
Source: FDA
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
