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FDA’s New RWE Guidance Provides Recommendations for Sponsors Conducting Non-Interventional Real-World Studies and Describes the Potential to Use RWE for Initial Approvals in One Limited Circumstance

FDA Law Blog

In contrast, as the guidance explains, a non-interventional study (also referred to as an observational study) is a type of study in which patients received the marketed drug of interest during routine medical practice and are not assigned to an intervention according to a protocol.

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New South Family Medicine and MedSpa Offers Next Level Care

New South Family Medicine and MedSpa

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

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Commissioner Makary Charts a New Course for FDA at FDLI Annual Conference

FDA Law Blog

Livornese Dr. Marty Makary took the stage on Thursday at the Food and Drug Law Institutes Annual Conference , continuing the tradition of Commissioners speaking at this event, but with a tone and tempo distinctly his own. Claud & Deborah L.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science. FDA, in other words, directed, and continues to direct, pregnant women to a learned intermediary.

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Communication

Mere Mortal MD

I take care of many patients who have had back surgery, and let me tell you, the recovery is no joke. When he expressed exasperation yesterday over having to know all the different types of hepatitis viruses and vaccines, I asked “Why are you having to learn about bloodborne pathogens? Hallelujah.

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RFK Jr. Hires Autism Skeptic To Look Into CDC Autism Data

Physician's Weekly

THURSDAY, June 12, 2025 (HealthDay News) — A longtime vaccine critic hired by Health Secretary Robert F. is reviewing safety data in an effort to revisit debunked claims that vaccines may cause autism. Geier and his late father, geneticist Mark Geier, spent decades promoting the idea that vaccines are linked to autism.

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Optimizing Nutrition in Aging: A Podcast with Anna Pleet, Elizabeth Eckstrom, and Emily Johnston

GeriPal

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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