FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

Manufacturing 105

Manufacturing Provider IT Electronics 105

Medical Xpress

JUNE 8, 2025

While many of these procedures provide critical care, we know they are acutely painful. Provided by The Conversation This article is republished from The Conversation under a Creative Commons license. The content is provided for information purposes only. During this time, they receive up to 16 painful procedures every day.

IT 53

IT Management Vaccination Medical 53

FDA Law Blog

APRIL 7, 2025

Lets take a look at these letters: Back in January 2025, CVM issued a Warning Letter to animal drug sponsor Elanco Animal Health. Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. that it is effective on Day 1) and insinuating misleading comparative claims.

Vaccination 64

Vaccination IT Manufacturing Screening 64

Physician's Weekly

JUNE 16, 2025

MONDAY, June 16, 2025 (HealthDay News) — A new COVID-19 variant that led to a spike in hospital cases across parts of Asia may now account for more than one-third of all COVID cases in the U.S., People may experience: Cough Sore throat Fever Tiredness As the virus continues to evolve, access to vaccines may change for some groups.

Vaccination 52

Vaccination Diabetes Illness Healthcare 52

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

cases in 2024-2025, H5N1 disease in humans had a high mortality rate of up to 50%. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. Several commercial laboratories are providing this service including Quest, LabCorp, ARUP and Mayo. Prior to the current U.S.

Patient-Centered 130

Patient-Centered Provider Manufacturing Screening 130

Physician's Weekly

JUNE 12, 2025

THURSDAY, June 12, 2025 (HealthDay News) — A newly approved shot could soon help protect babies from respiratory syncytial virus (RSV), the top cause of hospitalization in U.S. The new members include some vaccine critics. A vaccine given during pregnancy can also protect newborns, and together, these efforts seem to be working.

Hospital 52

Hospital Vaccination Clinic IT 52

Medical Xpress

JUNE 7, 2025

12 Tweet Share Email Home HIV & AIDS June 7, 2025 The GIST Long-lasting HIV prevention shot headed toward approval by I. © 2025 HealthDay. Citation : Long-lasting HIV prevention shot headed toward approval (2025, June 7) retrieved 9 June 2025 from [link] This document is subject to copyright. All rights reserved.

Vaccination 64

Vaccination Insurance Medical Diabetes 64

FDA Law Blog

AUGUST 14, 2022

The negotiations will result in a Maximum Fair Price (“MFP”) that the manufacturer must make available to providers furnishing the drug under Medicare Part B or pharmacies dispensing the drug under Part D. The same will be required under state Medicaid and CHIP programs by October 1, 2023.

Manufacturing 98

Manufacturing Government Vaccination Utilities 98

Maine Academy of Family Physicians

JUNE 21, 2024

Providers of abortion and gender affirming care in Maine are effectively shielded from laws in other states by the passage of protection by the legislature. Medicare Coverage of Recommended Vaccines – There is a split in coverage on vaccines in the Medicare program. LD 227 was signed by Governor Mills.

Family Physician 40

Family Physician Family Medicine DO Primary Care 40

Medical Xpress

JUNE 8, 2025

million surfs carried out each year in Victoria, researchers estimate that this could equate to more than 70,000 assists and almost 25,500 cases of first-aid provided by surfers annually. This is the first study to quantify surfer beach -safety actions, providing real-world implications of their impact. With more than 6.3

Provider 53

Provider Community Medical Diabetes 53

Medical Xpress

JUNE 23, 2025

Enzymes provide the body with instructions for what it needs to do, and when people lose energy and water, biochemical systems in the body start to fail, Wood says. Officials warn of increased risks for the elderly, outdoor workers and those without AC. Your blood pressure may decrease." Youve lost the ability to dissipate heat," he says.

Illness 53

Illness Engineering Nurse Practitioner Medical 53

Physicians News Digest

FEBRUARY 18, 2025

According to the CDC , the onset of the 2024-2025 flu season has been marked by an unusually high number of cases. These numbers highlight the critical impact of the outbreak, emphasizing the importance of vaccination and other preventive measures.

Vaccination 52

Vaccination Emergency Room Complication Healthcare 52

GeriPal

OCTOBER 31, 2024

Our conversation covers: The current state of COVID Evidence for COVID boosters, who should get them, and preferences between Novavax and mRNA vaccines COVID treatments like Molnupiravir and Paxlovid Differences in COVID impact on nursing home residents and those with serious illnesses We wrap up with a “magic wand” question. Is that right?

Vaccination 127

Vaccination IT Patient-Centered Patients 127

FDA Law Blog

SEPTEMBER 14, 2021

Beginning in 2025, payment for certain “Selected” single source drugs under Parts B and D, and under commercial plans that do not opt out of the program, would be limited to a Maximum Fair Price (MFP). A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged.

Manufacturing 52

Manufacturing Insurance Government Patients 52

Doctors for America

APRIL 29, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 April 29, 2025 FDA Task Force Statement on President Trump’s First 100 Days in Office WASHINGTON, D.C. The agency has also delayed vaccine advisory panels.

Medical Student 52

Medical Student Patients Individual Medical 52

Physician's Weekly

JUNE 13, 2025

A podcast producer and director emeritus of WOUB Public Media zeroed in on our article about restless doctors, sharing his thoughts on X: This must be Trump and Kennedy’s idiotic plan to make American Healthy Again… [link] — Tom Hodson (@thodson) May 29, 2025 — Tom Hodson, Athens, Ohio Oh, Canada Welcomes American Doctors! Kennedy Jr.’s

Vaccination 52

Vaccination Families Family IT 52

Physicians News Digest

APRIL 17, 2025

The Trump administration has canceled hundreds of grants supporting research on topics such as vaccination; diversity, equity, and inclusion; and the health of LGBTQ+ populations. Others followed the Senate confirmation of anti-vaccine activist Robert F. 28, are in states Trump won in November. Kennedy Jr. Kennedy Jr.

Vaccination 52

Vaccination Government Patient-Centered Hospital 52