Companion Diagnostics: US FDA Streamlines Risk Determinations In Oncology
Information about investigational drug and in vitro diagnostic may be submitted in single IND to agency's drugs or biologics centers, eliminating need for separate submission to devices center; new process should give greater therapeutic context to decisions of whether the IVD is considered a significant risk.
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US FDA has received a total of 19 reports of T-cell malignancy involving BCMA- or CD19-directed autologous CAR-T cell immunotherapies and is evaluating the need for regulatory action. Focus on lentiviral and retroviral vectors could extend to safety of other types of gene therapies.
Accelerated Approval Drugs’ Fate Rests Heavily On Current Therapeutic Landscape When Confirmatory Trials Are Overdue
At advisory committee meeting on Acrotech's two peripheral T-cell lymphoma drugs, FDA reviewers suggest they are more willing to seek product withdrawal for failure to conduct studies with due diligence when there are numerous available therapies.
Confirmatory Trials: Comprehensive Development Plan, Early Communication Will Help Reduce Delays, US FDA Says
Accelerated approval sponsors who want to demonstrate due diligence in conducting confirmatory trials should bring a comprehensive program for verifying benefit to the agency early and be proactive in communicating about challenges that could lead to delays, FDA’s oncology review staff say at an adcomm on delayed trials for Acrotech’s lymphoma drugs.