FDA Law Blog

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. His job was governed by an employment contract that contained both salary provisions and restrictive covenants.

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law Blog

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

Medical 53

Medical Diagnosis Healthcare Clinic 53

Tiny Physician

MARCH 30, 2022

Archana Sharma committed suicide because of the harassment by the bystanders of the patient who died at her hospital. However, she found herself in trouble when one of her patients, whom she treated at her hospital, died due to postpartum hemorrhage (bleeding from the birth canal after delivery). Is this a case of medical negligence?

Hospital 52

Hospital Government Patient-Centered Medical 52

GeriPal

MAY 12, 2022

So, we formed this organization called Pain and Palliative Care Society in the Northern Kerala city of Kalakkad based in the government medical college. But when I retired from government service, I left Kalakkad in 2002. Raj: We are not limited by definitions because we started our first non non-government organization.

Community 115

Community IT Relationship Healthcare 115

Common Sense Family Doctor

FEBRUARY 21, 2025

In two decades of practicing family medicine, I've never seen a patient with measles. Oh, and the CDC's National Immunization Survey has been canceled by the so-called Department of Government Efficiency, even if the Epidemic Intelligence Service seems to have received a temporary reprieve.) this is it.

Vaccination 52

Vaccination DO Family Medicine Hospital 52

Physician's Weekly

JUNE 25, 2025

Insurers also pledged to use clear language when communicating with patients and promised that medical professionals would review coverage denials. But health policy analysts say prior authorization — a system that forces some people to delay care or abandon treatment — may continue to pose serious health consequences for affected patients.

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Insurance Patient-Centered Patients Government 52

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

Physicians News Digest

APRIL 2, 2025

We were so nervous about not being on a company-provided plan,” Winard said. The fact that short-term plans can cover fewer services, conditions, and patients is why they are generally less expensive than an unsubsidized ACA plan. His plan says it covers colon cancer screening at 80% after patients meet their deductible.

Insurance 52

Insurance Screening Hospital Patient-Centered 52

Physicians News Digest

APRIL 3, 2025

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.

Patient-Centered 52

Patient-Centered Hospital Diagnose Medical 52

FDA Law Blog

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98

Physicians News Digest

APRIL 1, 2025

Since returning to the White House, Trump has said he will target fraud in Medicare, Medicaid, and Social Security, and his Republican allies in Congress have made combating fraud a key argument in their plans to slash spending on Medicaid, which provides health care for millions of low-income and disabled Americans.

Government 52

Government Insurance Patients Clinic 52