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.
FDA Law Blog
NOVEMBER 1, 2023
In fact, stakeholders have repeatedly challenged FDA’s assertions of authority in Citizen Petitions, public comments, and other forums. Premarket Approval or De Novo pathways). FDA’s position is, however, only one side of the story.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
JANUARY 12, 2025
Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).
FDA Law Blog
OCTOBER 14, 2024
California Stem Cell Treatment Center, Inc., 2014); U.S. At the clinics, Defendants offer treatments that consist of extracting fat tissue from patients and, through a multi-step process, turning that tissue into a liquefied mixture of stem cells, other cells and cell debris known as Stromal Vascular Fraction (SVF). By Steven J.
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
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. FDA-2022-E-3124 ).
FDA Law Blog
DECEMBER 11, 2023
Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It
Expert insights. Personalized for you.
130 
Let's personalize your content