Sound Physicians

MARCH 12, 2025

While we primarily partner with our own Sound specialty teams , we also work independently with employed and other outsourced clinical teams. With time, the partnership between tele-intensivists and hospitalists brings more confidence and allows for more patients — and patients with higher-acuity needs — to receive care locally.

Telemedicine 52

Telemedicine Community Hospital Patients 52

FDA Law Blog

JUNE 21, 2023

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. What medical technologies could be ideal to transition to use in non-clinical settings?

Medical 45

Medical Patients Healthcare Electronics 45

FDA Law Blog

OCTOBER 10, 2023

In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. Information about these typical non-clinical tests is generally based on previously released guidance documents for each topic, as linked above.

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

FDA Law Blog

SEPTEMBER 20, 2021

The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Today's Hospitalist

JUNE 7, 2025

They presented a rapid clinical update Webinar in May 2025 hosted by the Society of Hospital Medicine. ” All anti-obesity medications, even the earlier generation of these drugs—which include orlistat, phentermine, phentermine/topiramate (Qsymia) and naltrexone/bupropion (Contrave)—cause clinically significant weight loss.

Hospital 66

Hospital Management Diabetes Patients 66

FDA Law Blog

FEBRUARY 20, 2025

On February 19, 2025, Judge Sean Jordan in the Eastern District of Texas heard oral arguments in American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathologys (AMP) [1] lawsuit against the Department of Health and Human Services. The materials from this webinar are still available on FDAs website ( here ).

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102