FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

Clinic 64

Clinic IT Utilities Government 64

FDA Law Blog

JUNE 27, 2024

The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. Factor B was the pharmacy’s experience with dispensing or conducting research with respect to controlled substances while Factor D was compliance with applicable state, federal, or local laws relating to controlled substances.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. What hasn’t been shown, Eric, is that if you apply tools like this, clinical outcomes down the road are better for patients.

Screening 119

Screening Primary Care Patient-Centered IT 119

FDA Law Blog

JUNE 16, 2023

Identified drugs and related price information will be publicly disclosed, except for information the Board determines to be proprietary, not public, or trade secret. The Board may then initiate a cost review of any such identified drug product.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

AUGUST 3, 2022

3, 1992) (“It has come to the attention of FDA that laboratories have been manufacturing, “home brew” products, either from products already on the market, or from components, and utilizing these unapproved products for diagnostic purposes. These products are subject to the same regulatory requirements as any unapproved medical device”).

Lab Testing 98

Lab Testing Government IT Manufacturing 98

FDA Law Blog

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

GeriPal

JUNE 26, 2025

But from our clinical work, many of us are familiar with people with dementia who experience sudden shocks to their health, think hip fracture, think hospitalization for pneumonia. And the government can do something about that?!? Wait, so one key message is that social health is linked to physical and cognitive health?!?

Illness 73

Illness Hospital IT Patient-Centered 73

GeriPal

JULY 6, 2023

I think to some extent, the county doesn’t necessarily know what they don’t know about geriatrics, just like I don’t necessarily know what I don’t know about the county and local government and national government and state government. And then, the system responds in turn.

Community 89

Community Nurse Practitioner Provider IT 89

GeriPal

DECEMBER 21, 2023

And that’s where, based on this, I made a decision to leave University of North Carolina to come to Indiana University because my mentor, Chris Callahan, just received the grant from AHRQ to build the first randomized clinical control trial that evaluated the comprehensive dementia care model. ” Diane: Fantastic. And guess what?

Patient-Centered 125

Patient-Centered IT Families Family 125

FDA Law Blog

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional 59

Healthcare Professional Manufacturing Healthcare Utilities 59

GeriPal

JULY 20, 2023

We were the highest utilizers of telemedicine in the whole UCSF health system at that time which we’re very proud of. ” And I could tell you that’s a lot for a government agency to hear. If I have a clear referral in that’s two physicians agreeing this patient should be in my clinic and considered for opioids.”

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

Doctors for America

APRIL 29, 2025

Meaningful Clinical Experience: We were pleased to see President Trump appoint an individual with essential clinical and research experience to serve as the next FDA Commissioner. We hope that Commissioner Makary will utilize his experience to help ensure FDA puts patients over politics throughout his tenure.

Medical Student 52

Medical Student Patients Individual Medical 52

FDA Law Blog

SEPTEMBER 13, 2021

Medicare negotiation authority; encourage biosimilars and generic drug utilization). Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98