These guidance documents should provide greater reassurance to digital product developers about how and when FDA will classify and regulate their products.
Pharma companies and CROs are recognizing the need for focused electronic feasibility solutions to resolve challenges with processes managed in Excel trackers.
Overcoming the many known barriers to adopting and implementing an RBM program.
What can you do during your study to maximize your chances of success when it comes time to submit?
As more and more sites adopt eSource, the industry is poised for swift change and dramatic growth.
Learn six strategies for success when developing your companion diagnostic.
In a recent New York Times article, Paula Span raises the concern that elderly subjects are frequently omitted from clinical trials. Consequently, physicians know very little about how a given treatment may affect their older patients. Is a medication effective for the elderly? Is it safe? Without data, how is a physician to know?
An overview of the PMDA innovative, fast-track regulatory initiatives including the sakigake Designation System and the most recent Conditional Early Approval System.
This article summarizes progress from the initial imaging biomarkers developed to evaluate tumor shrinkage in response to cancer therapeutics, to the challenges posed by contemporary treatment paradigms which may produce new patterns of response.
There is a significant need to collect Real World Evidence (RWE) to demonstrate the benefit of these drugs in clinical practice which can then be used as the wrap around to demonstrate true clinical benefit and address all stakeholder needs.
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