Alabama Academy of Family Physicians

MAY 15, 2025

During the session, the Alabama Academy of Family Physicians actively represented the interests of its members on a range of healthcare initiatives. Pharmacy benefits managers would be further required to pass on 100 percent of rebates received from drug manufacturers to the health benefit plans for which they provide services.

Insurance 130

Insurance Family Physician Hospital Management 130

The Medical Futurist

JUNE 21, 2025

The 80-year-old Ray Flynn lost his central vision entirely, but with the help of the retinal implant, he could make out shapes on the computer screen. Experts even say the eye is an ideal place to start for the first clinical use of CRISPR. Google is not the only one working on A.I. solutions for eye care, though.

Diabetes 105

Diabetes Patient-Centered IT Patients 105

FDA Law

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. These LDTs are performed in clinical laboratories regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This proposed rule is a long-time coming.

Manufacturing 59

Manufacturing Clinic Screening Healthcare 59

FDA Law

AUGUST 23, 2022

The 80% sensitivity requirement for antigen tests has yet to be explained either scientifically or clinically by the Agency. After two negative tests, you should consider a molecular test, or call your healthcare provider. It is clearly rooted in fear that less sensitive tests may have too many false negatives.

Individual 97

Individual Clinic Healthcare Provider 97

GeriPal

MAY 5, 2022

Was there any mention about the impact that hearing loss has in communication or what we should do about it in clinical practice? 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. I’m guessing not.

IT 102

IT Screening Hospital Clinic 102

FDA Law

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that simulated use/leachables studies to simulate the clinical use (i.e., In the draft guidance, FDA illustrates the need for additional orthogonal data (i.e.,

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law

OCTOBER 10, 2023

airport security screening), or surgical procedures, as well as the potential for reoperation or revision of the implant. Non-Clinical Recommendations The draft guidance highlights non-clinical review areas that are generally relevant across 510(k) Implants and offers recommendations for performance data to include in a 510(k) submission.

Manufacturing 45

Manufacturing Engineering Clinic Patients 45