FDA Law Blog

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

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FDA Law Blog

AUGUST 21, 2023

Further, FDA has utilized a variety of strategies to call attention to safety issues through Dear Doctor letters or other forms of communication, even if directing changes to labeling is difficult. Koblitz & Deborah L. Agency officials estimated that it took at least 6 years to complete the required rulemaking process.”

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New South Family Medicine and MedSpa

NOVEMBER 24, 2022

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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Family Medicine DO Families Family 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

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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Referral Family Medicine DO Primary Care 40

FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

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Manufacturing Government Vaccination Utilities 98

PEMBlog

APRIL 4, 2024

But there are some challenges when it comes to the utilization of FOAM: – Decentralization of FOAM resources – Concerns about the quality of information being presented The Solution: The Systematic Online Academic Resource, or SOAR, review was created in an effort to address some of these limitations. How can I use these findings?

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Education Utilities Vaccination IT 59

FDA Law Blog

SEPTEMBER 14, 2021

A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. The Part B rebate would exclude vaccines as well. This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing.

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Manufacturing Insurance Government Patients 52

Doctors for America

APRIL 29, 2025

However, this assessment comes with alarm – essential services our patients rely on and that we as clinicians need to provide high-quality, evidence-based care have been obliterated by seemingly haphazard decision-making. The agency has also delayed vaccine advisory panels.

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