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.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law Blog

FEBRUARY 22, 2022

We identified as the main culprit FDA’s requirement that these tests achieve 80% sensitivity (positive percent agreement or PPA) even when a required percentage of low positive patients are included. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing 52

Manufacturing Screening Provider Clinic 52

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. Senate SB 43 – Patient Price Transparency Bill What’s in the Bill: Sponsored by Sen.

Insurance 130

Insurance Management Hospital Vaccination 130

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. Then fast forward a year.

Illness 109

Illness IT Patient-Centered Patients 109

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. Several commercial laboratories are providing this service including Quest, LabCorp, ARUP and Mayo.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

GeriPal

DECEMBER 7, 2023

What do we do to very concretely provide heat shelters and cool shelters? Ruth: And then to answer your question also about the different providers as far as nurses and physicians and respiratory therapists and pharmacists, most schools of medicine, nursing and all those other fields are including some climate change in their curriculum.

Healthcare 130

Healthcare IT Education Community 130

FDA Law Blog

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

Medical 59

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. We were so nervous about not being on a company-provided plan,” Winard said. There are several ways to screen, including noninvasive stool tests. Preventive Services Task Force.

Insurance 52

Insurance Screening Hospital Patient-Centered 52