FDA Law Blog

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements. We should explain what RIEs are.

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Manufacturing Clinic IT Utilities 105

FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. Any application from a State or Federal Government entity. Exemptions or Waivers.

Medical 59

Medical Provider IT Manufacturing 59

FDA Law Blog

NOVEMBER 6, 2022

In September 2020, the OIG issued an unfavorable advisory opinion to Pfizer, concluding that the proposal was “highly suspect” under the AKS because one purpose of the program, and perhaps the primary purpose, would be to induce Medicare beneficiaries to purchase Pfizer’s federally reimbursable medication. Pfizer’s Petition to SCOTUS.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

GeriPal

JUNE 26, 2025

And the government can do something about that?!? Disruptive events are medical, surgical. And hospitalization for pneumonia is like a medical event. And maybe we’ll turn now from these medical and surgical events to start talking about social events. I have no idea what that is. Any other social events?

Illness 52

Illness Hospital IT Patient-Centered 52

FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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Clinic Clinical Practice Provider Utilities 64

FDA Law Blog

JUNE 27, 2024

Alternating Between Cash and Insurance According to the government’s expert, patients paying for prescriptions with insurance and for others with cash is a red flag for those paid with cash. paid for some medications with insurance while paying for other controlled medications in cash, and Patient M.W. 21 U.S.C. § at 50,376.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. It was alleged that other employees administered the medication to patients even after observing signs of tampering, although no patients were reported harmed.

Board-Certified 52

Board-Certified Provider Government Management 52

GeriPal

JULY 19, 2024

We didn’t have medications that were effective with a few side effects. So I think we’re poised now with the guide model and with the evidence we have about healthcare utilization, impact on caregivers, course of dementia, comorbidity management and all of that. I don’t have access to change the levers of government.

Screening 120

Screening Primary Care Patient-Centered IT 120

FDA Law Blog

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. FDA has model recall communication templates available here that firms can utilize. Most FDA-regulated entities have an established SOP that governs the evaluation, decision, notification, and process for conducting a recall. By Philip Won & Lisa M.

Electronics 40

Electronics Manufacturing Provider IT 40

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

PEMBlog

MAY 24, 2023

This entails utilizing the least invasive non-pharmacologic means of assisting them, before moving to physical or chemical restraints. Government. Patient that are agitated should always be treated with dignity and respect.

Management 54

Management Patient-Centered Physicals Finance 54

GeriPal

JANUARY 20, 2023

There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. Part of it’s what Mike was saying, it’s accountability as a country, as a nation and as the government. This is a problem that’s existed for decades. What are they accountable for?

Finance 95

Finance Board-Certified IT Provider 95

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. The preamble notes that this information would help ensure that drugs are being used for approved or otherwise medically accepted indications.

Manufacturing 59

Manufacturing Vaccination Government Diagnosis 59

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. They’re afraid of losing their independence.

Community 89

Community Nurse Practitioner Provider IT 89

FDA Law Blog

AUGUST 14, 2022

Starting July 1, 2023, the IRA will also limit to $35 the total monthly contribution by a Medicare Part B beneficiary for insulin purchased through a durable medical equipment (“DME”) supplier. In return for providing the MFP, manufacturers of selected drugs do receive coverage, but high utilization drugs are certain to have coverage anyway.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

GeriPal

DECEMBER 21, 2023

But for other- Diane: And it’s on the medical side. The typical utilization of inappropriate hospitalization and emergency room and total cost of care. Just to let you know, Eric, we have to give the credit to our federal government. Some of these models I think include more medication management, some of them don’t.

Patient-Centered 126

Patient-Centered IT Families Family 126

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

Alex: We are delighted to welcome Joe Rotella, who’s the Chief Medical Officer of the American Academy of Hospice and Palliative Medicine. We were the highest utilizers of telemedicine in the whole UCSF health system at that time which we’re very proud of. So now that the emergency response has ended, what’s to be done?

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

Doctors for America

APRIL 29, 2025

We hope that Commissioner Makary will utilize his experience to help ensure FDA puts patients over politics throughout his tenure. Both Secretary Kennedy and Commissioner Makary have proposed strategies to mitigate the “revolving door” between the government and the industries they regulate.

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Medical Student Patients Medical Individual 52