FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles.

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Provider Medical Manufacturing Consulting 59

FDA Law Blog

AUGUST 23, 2022

This lack of uniformity across manufacturers may place an unfair stigma on the newest entrants to the market as being fundamentally less accurate when that may not be the case. The NIH RADx-sponsored study mentioned in the safety communication addresses a data gap in FDA’s review of antigen tests.

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Individual Clinic Healthcare Provider 97

GeriPal

MAY 5, 2022

Screening for addressing hearing loss should be an integral part of what we do in geriatrics and palliative care, but it often is either a passing thought or completely ignored. How to screen for hearing loss. Eric: And how do we screen for it? Communication techniques we can use when talking to individuals with hearing loss.

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IT Screening Hospital Clinic 102

FDA Law Blog

OCTOBER 10, 2023

airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. We find that this information is noteworthy for manufacturers to consider. For instance, FDA highlights risks associated with everyday activities (e.g., separate patient labeling). separate patient labeling).

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Manufacturing Engineering Clinic Patients 45

FDA Law Blog

MAY 17, 2021

suited for, like back to work screening. 19 LDTs 10 months ago, but it has deprioritized EUAs for virtually all PCR tests that must be sent to laboratories (even those that are not LDTs). The hot ticket these days is rapid antigen testing to satisfy other testing priorities that PCR testing is less well?suited

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Manufacturing IT Screening Medical 52

FDA Law Blog

MAY 17, 2021

suited for, like back to work screening. 19 LDTs 10 months ago, but it has deprioritized EUAs for virtually all PCR tests that must be sent to laboratories (even those that are not LDTs). The hot ticket these days is rapid antigen testing to satisfy other testing priorities that PCR testing is less well?suited

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Manufacturing IT Screening Medical 40

GeriPal

JUNE 20, 2024

Do you screen for lower urinary tract symptoms, incontinence, and if so, how? If I was going to ask one question about this just as a screen, is there a way to ask this question that is not both stigmatizing, but people also understand and it gets around some of these issues. Eric 08:05 Yeah. Eric 08:19 Sure thing, if I’m honest.

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IT Patient-Centered Patients Clinic 121

FDA Law Blog

NOVEMBER 18, 2021

Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence of an active SARS?CoV?2 A positive result, however, is treated as a screen. That is just another way of saying, however, that the rapid antigen tests are best positioned as a screening tool. Why is that?

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Screening Healthcare IT Manufacturing 98

FDA Law Blog

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

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Manufacturing Screening Provider Clinic 52

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

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Manufacturing Provider Physicals Electronics 64

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

Ed Oliver, HB 45 would require the Alabama Medicaid Agency to cover any noninvasive colorectal cancer screening test assigned a grade A or B under the recommendations of the United States Preventive Services Task Force. This bill would also require the Alabama Medicaid Agency to cover a colonoscopy based on a positive test result.

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Insurance Management Hospital Vaccination 130

GeriPal

MAY 8, 2025

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? They communicated by looking at a letter screen and it would track his eye movements. So I can say anything I want. I am not sticking my foot in my mouth.

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Illness IT Patient-Centered Patients 109

FDA Law Blog

APRIL 7, 2025

Elanco is the manufacturer of recently approved Zenrelia (ilunocitinib tablets) (September 2024), which is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. The detail with which CVM reviewed these promotions is reminiscent of OPDP/DDMAC letters of yore.

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Vaccination IT Manufacturing Screening 64

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. H5N1 is currently known to be widespread among wild birds and is thought to be spread by migratory waterfowl.

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Patient-Centered Provider Manufacturing Screening 130

GeriPal

DECEMBER 7, 2023

We’re that middle area where whether it be our clinics, in the operating rooms- Leslie: You are talking about a network of corporations, of manufacturers, of suppliers, of scientific research groups. Ruth: That’s not prevention, that’s screening. I mean, you are talking about a huge, huge network.

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Healthcare IT Education Community 130

FDA Law Blog

NOVEMBER 8, 2022

For whose manufacturers who do not intend to continue device distribution, FDA generally does not intend to request market removal of those devices distributed before the applicable EUA termination or guidance withdrawal date. Maisel also discussed disposition of already distributed devices. CDRH Town Hall.

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Medical Manufacturing Patient-Centered Provider 59

Physicians News Digest

APRIL 2, 2025

By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business. The Medical Procedure Periodic colon cancer screening is recommended for people at average risk starting at age 45 and continuing until age 75, according to the U.S.

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Insurance Screening Hospital Patient-Centered 52