2014 Medical Patient-Centered Provider 
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. For this reason, medical experts classify DCIS as noninvasive. This is why conventional physicians treat DCIS in patients with surgery, radiation, and sometimes chemotherapy.
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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Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway.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
Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.
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.
FDA Law Blog
DECEMBER 11, 2023
6] It is inconsistent to say that LDTs must be regulated as medical devices because of the newness of the tests and then reduce the cost of the proposed regulation by declaring that half of all LDTs will be exempt from premarket review. That seems very unlikely to be the case, because exemptions apply only to well-established tests.
FDA Law Blog
FEBRUARY 29, 2024
As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.
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