FDA Law

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device.

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Provider Medical Manufacturing Consulting 59

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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Hospital Manufacturing Specialization Medical 52

Physician's Practice

JUNE 9, 2025

a health care attorney with Roetzel & Andress, joins the show to explore the legal risks of prescribing GLP-1 medications. Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. Adler, J.D.,

Management 52

Management Telemedicine Insurance Patients 52

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. §

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Clinic Patient-Centered Asthma Patients 59

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.

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Manufacturing Government Medical IT 40

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. Hearing aids, you had six big manufacturers of hearing aids. Five big manufacturers. Transcript.

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IT Screening Hospital Clinic 102

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. It’s not a controlled substance medication. J Am Geriatr Soc. Eric: Are these generic?

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Patient-Centered IT Healthcare Medical 96

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.

Manufacturing 52

Manufacturing IT Government Medical 52

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.

Manufacturing 52

Manufacturing IT Government Patients 52

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. So medication adjustments. Gordon Alwasa. Am I saying that right? I always get. Like all of.

Illness 107

Illness IT Patient-Centered Patients 107

FDA Law

JANUARY 3, 2024

The unapproved drug claims are not, in and of themselves, notable, but it is always interesting when FDA takes a stand against such a large swath of manufacturers and distributors at the same time. And CVM certainly exercises that authority.

Manufacturing 59

Manufacturing Education Patient-Centered Vaccination 59

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. And I don’t think necessarily, that appointment needs to be a medicalized process. If you’re new to this discussion, don’t start with this podcast! Who are they?

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Illness IT Healthcare Patient-Centered 72

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.

IT 52

IT Vaccination Manufacturing Medical 52

GeriPal

DECEMBER 7, 2023

And on that, I found a link to this article by Rick Moody called Elders in Climate Change, No Excuses, in which he argues that elders are the group that benefited most from the massive consumption of fossil fuels in the post World War II eras. I mean, many people in their mid to older years are on certain medications. Ruth: Right.

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Healthcare IT Education Community 129

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.

Vaccination 52

Vaccination Government Physicals IT 52

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. .” His commission is now working on a plan of action. Studies Derailed The MAHA report says environmental chemicals may pose risks to children’s health.

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