FDA Law

JUNE 28, 2021

If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. Manufacturers would still be required to report sales of these products to the Board of Pharmacy, but they would not be factored into the determination of the opiate product registration fee.

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GeriPal

MAY 5, 2022

If you want to take a deeper dive into this subject and read some of the articles we discussed in the podcast, check out the following: Hearing Loss: Effect on Hospice and Palliative Care Through the Eyes of Practitioners. Think about the last time you attended a talk on communication skills or goals of care discussions. I’m guessing not.

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FDA Law

OCTOBER 14, 2024

Regulatory Background FDA regulates and generally requires premarket approval of all new drugs, which are defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.” 21 U.S.C. § Robbins , 519 U.S. Wilkie , 588 U.S.

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FDA Law

APRIL 19, 2021

Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device. Two judges on the D.C.

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GeriPal

MARCH 2, 2023

I could go on and on, but listen to the podcast instead and for a deeper dive, take a look at the following articles and studies: Gabapentin in the Perioperative setting: Prolonged use of newly prescribed gabapentin after surgery. By 2015 that number increased to 4% of US adults. J Am Geriatr Soc. Tasce: I do. Tasce: Yes. Taylor Swift.

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GeriPal

MAY 8, 2025

And it kind of made its way into medicine probably around, I’m going to say the 50s after there was a fairly interesting Time Life article that was published. And when that article went to print, it just went ballistic. I’m actually going to show you a picture of the green doors just so you can see it. It’s there.

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Illness IT Patient-Centered Patients 106

FDA Law

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. As we chronicle in an article that appears in the current edition of the Food and Drug Law Journal , FDA’s policies for reviewing COVID assays, have been a contributing factor.

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FDA Law

JANUARY 3, 2022

Unlike March 2020, numerous tests by multiple manufacturers have been reviewed by FDA and are being distributed. As we chronicle in an article that appears in the current edition of the Food and Drug Law Journal , FDA’s policies for reviewing COVID assays, have been a contributing factor.

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GeriPal

MARCH 24, 2022

Start by reading this article by Sean Morrison, Diane Meier, and Bob Arnold in JAMA , and this response from Rebecca Sudore, Susan Hickman, and Anne Walling. This is the latest in our series of podcasts on concerns about, and potential of advance care planning. If you’re new to this discussion, don’t start with this podcast! Here we go.

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FDA Law

JANUARY 3, 2024

To carry out its mission, CVM has the same enforcement tools that the rest of FDA, like CDER and CDRH, have, including the authority to conduct inspections, issue warning letters, seize products, add manufacturers to import alerts, and impose penalties on bad actors. Enter the FDA’s Center for Veterinary Medicine (“CVM”).

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FDA Law

FEBRUARY 4, 2025

As our readers may already know, FDA maintained three PRV programs to incentivize the development of therapies for underfunded diseases: the RPD PRV program, which sunset last month, the Medical Countermeasures (MCM) PRV Program, which sunset in October 2023, and the Tropical Disease PRV Program.

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GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

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Tiny Physician

OCTOBER 17, 2021

Indian Medical Association (IMA) Kerala wing criticized the minister at that time as the medicine lacked scientific evidence (2). In this article, I will explain why this homeopathic remedy shouldn’t be distributed in our schools for children. However, there is no clinical trial on its effect on COVID 19 infection or its complications.

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Physician's Weekly

JULY 3, 2025

Spokespeople for the White House and Department of Health and Human Services did not respond to questions for this article. The Trump administration has declared that it will aggressively combat chronic disease in America. But the administration is seeking to cut government funding that could serve as a counterweight. Kennedy Jr.

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