FDA Law

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. In March of this year, FDA convened the first public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review.

Patient-Centered 52

Patient-Centered Clinic Medical Utilities 52

FDA Law

OCTOBER 6, 2023

The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. The phase out period applies to LDTs currently on the market in reliance on FDA’s enforcement discretion policy (“affected laboratories”). Part 803 and notices of correction and removal under 21 C.F.R.

Provider 64

Provider Manufacturing IT Medical 64

FDA Law

APRIL 14, 2022

Cato — On March 22, FDA announced that it reached agreement with representatives from the medical device industry on proposed recommendations to Congress for the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V). MDUFA V would be applicable to fiscal years 2023 through 2027.

Provider 40

Provider Clinic Medical IT 40

FDA Law

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027). up to 125 total products enrolled through FY 2025).

Manufacturing 45

Manufacturing Medical Appointment Patient-Centered 45

GeriPal

APRIL 3, 2025

That was actually Ken, you remember that article, Nancy Schoenberg’s article on screening and what to say and what not to say to patients on how to talk. How to talk to patients about screening colonoscopies. It always has clinical relevance to practice today. Ken 09:56 We did a role play. We did a role play.

IT 64

IT Hospital Screening Patients 64

Physician's Weekly

JUNE 25, 2025

Dozens of insurance companies, including Cigna, Aetna, Humana, and UnitedHealthcare, agreed to several measures, which include making fewer medical procedures subject to prior authorization and speeding up the review process. “This is an opportunity for the industry to show itself.” Reform efforts aren’t new.

Insurance 52

Insurance Patient-Centered Patients Government 52

Physician's Weekly

JULY 2, 2025

“It’s so expensive,” said Maria, who often works 12-hour days lifting clients in and out of bed and helping them with hygiene, medication management, and housework. The state Department of Health Care Services, which oversees Medi-Cal, partnered with community health clinics to help get eligible people enrolled.

Community 52

Community Government Insurance Provider 52