Today, the FDA issued draft guidance outlining a new regulatory pathway intended to help sponsors gain approval for highly ...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teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...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 ...
Clinical Trials Arena on MSN
Gene editing takes centre stage in FDA’s new rare disease approval pathway
The aim of the pathway is to remove red tape for bespoke therapies designed for patients with rare diseases.
An oncology expert explains how clinical and non-clinical evidence impact the clinical pathway decision-making for patients with NSCLC. Edward Arrowsmith, MD: We have a couple ways that we're tracking ...
The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...
(MENAFN- EIN Presswire) EINPresswire/ -- As oncology innovation accelerates and evidence evolves faster than traditional pathway update cycles, stakeholders need clearer insight into how clinical ...
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 ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results