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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

Even though an IND is not required, this guidance is intended to provide recommendations for sponsors to follow for using RWE from such studies for regulatory decision-making. The COVID-19 vaccines were initially authorized under EUAs, but their approvals do not appear to have been based on RWE.

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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. 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.

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Anatomy of a Healthy Plate- Guest Blogger Rebecca Gray

New South Family Medicine and MedSpa

Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories. Folate (folic acid) helps the body form red blood cells.

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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) Liability is precisely why the vaccine market shrunk so significantly in the 1980s, going from 26 manufacturers to 4, after lawsuits claiming $3.5

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Utilizing Community Outreach Workers to address COVID-19 Misinformation [COVID-19]

Annals of Family Medicine

Background: The University of Maryland School of Medicine (UMSOM) combats COVID-19 misinformation in youth to reduce vaccine hesitancy through targeted outreach and education. Methods: UMSOM connected with organizations that have roots in local communities in areas with high vaccine hesitancy rates.

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Measles has been confirmed in Iowa, here’s how to protect your family.

Family Physicians of Cedar Rapids

We know how much parents have on their plates these days with school events, summer plans, sports, and simply trying to keep kids healthy and safe. thanks to vaccines but with declining vaccination rates, it’s made a comeback. How to Keep Your Family Protected Check those vaccines. It was nearly eliminated in the U.S.

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New drug shows promise for fighting both COVID-19 and cancer

Medical Xpress

While vaccination can provide life-saving protection against COVID-19, scientists are still searching for ways to treat severe infections, including in people who cannot get vaccinated or in the event that dangerous new strains of the virus arise that could bypass vaccine protection.