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Access to health care and services for the Deaf: A scoping review of reviews [Health care services, delivery, and financing]

Annals of Family Medicine

A consultation was conducted with eight members of the Deaf community to complete the results. A community consultation identified the evaluation of the cost of providing sign language interpreters (or not) as a top research priority. 2010) and adapted by Schultz et al. Popay et al.’s Population Studied: Deaf adults.

Finance 130
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Green Practice News: April 2025

My Green Doctor

from 2000 to 2018 among people over 65 years old. The Power of Healthcare Professionals as Trusted Messengers Patients Trust Their Healthcare Providers A recent study found that 64% of physicians recognize environmental sustainability affects their patients’ health, yet only 17% feel comfortable discussing it ( PubMed ).

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New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law Blog

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. of ISO 10993-1:2018, but is extremely burdensome and not referenced in the related ISO 10993-18. By Adrienne R.

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FDA’s Third Party Review Program is Ready for the Next Pandemic, not the LDT Final Rule

FDA Law Blog

The final guidance looks much like the prior draft and is intended to satisfy FDAs obligation to issue final guidance on consultations with persons under section 565(i) of the FD&C Act and also to provide clarity on use of third party emergency use authorization (EUA) review. Fiscal Year 2023 showed similar performance.

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How Many Hours are Really in a Day?

FDA Law Blog

We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. the new draft guidance and ISO 10993-1: 2018) leads to more uncertainty for sponsors.

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Caring for Patients with Duchenne Muscular Dystrophy in the Emergency Department: A Problem-Based Approach

PEMBlog

Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. 2018 Oct;142(Suppl 2):S72-S81. 2018-0333I. DMD patients often receive yearly MRIs to monitor their cardiac health, as discrepancies between MRI and echo findings are common.

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Every Day Counts for PTE: Court Finds FDA’s Reinterpretation of Testing Phase Arbitrary and Capricious

FDA Law Blog

In February 2018, however, FDA issued a PTE decision determining that the testing phase for a NADA starts only once a Notice of Claimed Investigational Exemption (“NCIE”)—a written notification to FDA under an INAD of the sponsor’s intent to ship an investigational new animal drug—has been submitted. When the U.S.