Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

As healthcare becomes more entrenched in the digital revolution, the need for an approved set of protocols for care delivery — clinical pathways — is becoming increasingly critical. Clinical pathways, ...

The framework, first introduced by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research head Vinay ...

The aim of the pathway is to remove red tape for bespoke therapies designed for patients with rare diseases.

The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...

Edward "Ted" Arrowsmith, MD, MPH, medical director for pathways at OneOncology and managing partner at Tennessee Oncology, talks about challenges and changes in clinical pathways and the importance of ...

For many healthtech innovators the real adoption challenge is not always in proving the clinical value of their product. It is overcoming structural barriers that stand in their way. So, let’s explore ...

Despite advances in clinical cancer care, cancer survivors frequently report a range of persisting issues, unmet needs, and concerns that limit their ability to participate in life roles and reduce ...

Linda Bosserman, M.D., joined City of Hope in Los Angeles nine years ago as a medical oncologist specializing in breast cancer and value-based care. During her 26 years in private practice, prior to ...