FDA Law Blog

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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FDA Law Blog

SEPTEMBER 29, 2023

For more than 30 years, FDA has asserted that it has jurisdiction to regulate LDTs as medical devices and clinical laboratories as manufacturers. Nevertheless, the Agency believes this bifurcated system presents public health risks, and needs to be corrected by bringing LDTs under the FDA’s general IVD regulatory framework.

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GeriPal

JUNE 20, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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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. § 820.198).

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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

GeriPal

MAY 8, 2025

Alex 00:59 And I met all three of you and watched you do a presentation about psilocybin research at the Congress International Desens Palliative Miguel. 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?

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Illness IT Patient-Centered Patients 107

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

By Wes Stubblefield, MD, MPH, FAAP ADPH Medical Officer H5N1 influenza, or “bird flu,” is a type of influenza that was first discovered in the 1950s. Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities.

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