Under new platform, drugs could soon be approved with accompanying software applications that could monitor adverse events or patient compliance without a separate premarket device review.
The US FDA expects to soon release its digital health tools platform that will allow software applications to be approved in conjunction with new drugs and included in labeling.
Under the plan, these software applications may not require separate approval by the Center for Devices and Radiological Health. Commissioner...
The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.
The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation that require clarification, says pharmaceutical industry federation EFPIA.
Europe’s Innovative Health Initiative, a public-private funding partnership, has put out a call for a research project that could help analyze the use of regulatory sandboxes in health care innovation in addition to three others.
In an interview with the Pink Sheet, Troy Tazbaz, director of the US FDA's Digital Health Center of Excellence, says the agency lacks authority to regulate assurance labs, which would be used to help AI developers ensure their models are working correctly before submitting them for approval.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
