Annals of Family Medicine
NOVEMBER 20, 2024
Context: Genomic and personalized medicine implementation efforts have largely centered on specialty care in tertiary health systems. In 2014, Endeavor Health (formerly NorthShore University HealthSystem) launched the Center for Personalized Medicine to catalyze the delivery of personalized medicine.
AMMD
FEBRUARY 14, 2025
My first breast cancer scare was in 2014, when they discovered calcifications for the first time during a routine mammogram. This is why conventional physicians treat DCIS in patients with surgery, radiation, and sometimes chemotherapy. There are also the luminal epithelial cells closest to the center.
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FDA Law Blog
JANUARY 12, 2025
Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. However, the 2014 Guidance cannot be ignored entirely. By Charles G. Raver & James E. Valentine & Ellis Unger & Frank J.
FDA Law Blog
NOVEMBER 1, 2023
Indeed, recent jurisdictional developments suggest that a wide of array of stakeholders could have standing to challenge the Agency’s attempt to restrict access to commonly used LDTs, including individual laboratories, hospitals, physicians and healthcare providers who routinely use these tests, and patients who depend on them.
FDA Law Blog
JUNE 23, 2021
Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E. The practice of medicine was viewed as paternalistic.
FDA Law Blog
FEBRUARY 29, 2024
If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.
FDA Law Blog
DECEMBER 11, 2023
Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. Thus, it is wholly unrealistic for the Third-Party Review Program to provide any meaningful reduction in Agency workload. Certain points are indisputable.
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