FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). Specifically, that it allows for fast production of “patient-matched devices” (i.e.,

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FDA Law Blog

APRIL 20, 2022

FDA approved Firdapse for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adult patients in November 2018 with orphan drug exclusivity and subsequently approved a second amifampridine product, Ruzurgi, in May 2019 for the treatment of pediatric patients with LEMS.

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IT Patients Government 52

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.

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Lab Testing Individual Referral Patient-Centered 52

The Clinical Problem Solvers

AUGUST 25, 2020

Pearls Defining Structural Racism Structural racism is a term that acknowledges that racism is perpetuated beyond individual interactions and interpersonal racism, but is present in the systems and policies that govern our everyday lives. N Engl J Med 2020; 383:197-199. doi: 10.1016/S0140-6736(18)31130-9.

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Community Patient-Centered Relationship Education 52

FDA Law Blog

JUNE 16, 2023

The Board is not required to identify all drugs that meet the above criteria and may, in consultation with the advisory council and the commissioner of health, identify drug products that fall outside these criteria but otherwise could create “significant affordability challenges” for Minnesota’s healthcare system or Minnesota patients.

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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.

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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.

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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?

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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.

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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.

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Common Sense Family Doctor

MARCH 23, 2025

This post first appeared on March 6, 2018, during the first Trump administration's failed attempt to eliminate the Agency for Healthcare Research and Quality (AHRQ). Now the Department of Government Efficiency is trying again, threatening 90% staff reductions that would decimate the agency. Update: the NGC ceased operating in 2018.]

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Healthcare Patient-Centered Primary Care Illness 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.

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Healthcare Professional Manufacturing Healthcare Utilities 59

Physicians News Digest

APRIL 2, 2025

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. Many do not include drug coverage or maternity care. Capitol, and at the White House.

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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.

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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.

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Manufacturing Supply Chain Patient-Centered Utilities 98

Physicians News Digest

APRIL 1, 2025

And as one of the first actions of his second term, Trump fired 17 independent inspectors general responsible for rooting out fraud and waste in government. “It To prevent more fraud, the programs would likely need to be redesigned in ways that would be slower and more cumbersome for all patients, Elberg said.

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Government Insurance Patients Clinic 52