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In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. products intended for medical purposes).

Medical 98

Medical Manufacturing Healthcare Government 98

FDA Law Blog

AUGUST 29, 2021

The federal government does its own version of rebranding with each change in administration. This policy, announced by then Associate Attorney General Rachel Brand in 2018 was referred to as the Brand Memo. Walsh & JP Ellison — Companies often use rebranding to reposition and refocus their business.

Government 52

Government Electronics IT Clinic 52

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In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. products intended for medical purposes).

Medical 75

Medical Manufacturing Healthcare Government 75

BMJ

JULY 17, 2020

Many Chinese expressed their disapproval of the many untrusted sources of information online while demonstrating a high level of trust towards the central government. Shaanxi, Xi’an, China: Shaanxi Normal University; 2018. Yet, as Tenkorang 7 made the point, it is simply not enough to only implement approaches at the community level.

Community 40

Community Individual Physicals Finance 40

FDA Law Blog

SEPTEMBER 29, 2021

Manufacturers may choose not to participate in this program, but the federal government will not reimburse for their outpatient drugs under Medicaid or Medicare Part B if they do not. A 2018 report by the Government Accountability Office (“GAO”) found similar issues, as well as contract pharmacy noncompliance and poor federal oversight.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law Blog

OCTOBER 25, 2021

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

Manufacturing 52

Manufacturing Government Specialization IT 52

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. Becerra got a lot of attention. Britney Jean Spears.

IT 52

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.

Lab Testing 52

Lab Testing Referral Individual 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.

Community 52

Community Patient-Centered Relationship Education 52

FDA Law Blog

JUNE 16, 2023

Importantly, “price increase” is not defined in this statute. It appears not to mean a WAC increase, because the term WAC is specifically used in defining the price increase triggers, but not in reference to the manufacturer’s price increase. If a price increase is not an increase in WAC, its meaning is unclear. Is it an increase in AWP/SWP?

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 Referral Individual Patient-Centered 40

GeriPal

MARCH 2, 2023

JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. Tasce: I do.

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. Emphasis added.)

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

MAY 12, 2022

Raj faced in pain management: access to opioids, corruption, a system that doesn’t see addressing suffering as a priority. Prognosis communication and the subtle ways we may communicate it without intention. Social pain and loneliness. Community-based palliative care networks . Raj’s reflections on the state of palliative care in the US. Transcript.

Community 115

Community IT Relationship Healthcare 115

Tiny Physician

MARCH 30, 2022

Government’s response The Chief Minister of Rajasthan, Mr. Ashok Gehlot, on Wednesday evening tweeted that a high-level meeting was held at the Chief Minister’s residence to discuss the case of suicide and it was decided to take action against the SP of Dausa district, Mr. Anil Kumar; and SHO of Lalsot.

Hospital 52

Hospital Government Patient-Centered Medical 52

Common Sense Family Doctor

FEBRUARY 21, 2025

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.) In two decades of practicing family medicine, I've never seen a patient with measles. this is it. over the past 30 years.

Vaccination 52

Vaccination Family Medicine DO Hospital 52

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.]

Healthcare 52

Healthcare Patient-Centered Primary Care Illness 52

Physician's Weekly

JUNE 25, 2025

But government interventions to improve prior authorization will be used “if we’re forced to use them,” Oz said during the news conference. Insurers also pledged to use clear language when communicating with patients and promised that medical professionals would review coverage denials. Reform efforts aren’t new.

Insurance 52

Insurance Patient-Centered Government Patients 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

Physician's Weekly

JUNE 25, 2025

In the 1980s, the government refused to acknowledge HIV as gay men died young. — Cedric Sturdevant woke up with “a bit of depression” but made it to church, as he does every Sunday. In a few days, he would drive from Mississippi to Washington, D.C., About 40% of adults with HIV rely on it for their lifesaving treatments.

Government 52

Government Community Families Family 52

Physicians News Digest

APRIL 2, 2025

The federal government offers subsidies based on household income for ACA plans, which can make them comparable in cost to cheaper, short-term plans — but with a wider range of benefits. By Julie Appleby Tim Winard knew he needed to buy health insurance when he left his management job in manufacturing to launch his own business.

Insurance 52

Insurance Screening Hospital Patient-Centered 52

FDA Law Blog

MAY 26, 2025

Below, we highlight some of the challenges we would see in the governments attempt to pursue these cases. 2018), the district court ruled that Congress had exceed its constitutional bounds and had no authority to pass this law under the Necessary and Proper Clause or the Commerce Clause. 18-1156, 2018 U.S. MedImmune, Inc.

Manufacturing 59

Manufacturing Provider Medical General Practice 59

Physicians News Digest

APRIL 3, 2025

At their first meeting with the leadership of AHRQ last month, officials from Trump’s Department of Government Efficiency said that they didn’t know what the agency did — and that its budget would be cut by 80% to 90%, according to two people with knowledge of the meeting who were granted anonymity because of fears of retribution.

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. Last Thursday, the U.S. The actual policy proposals read like a wish list. LEGISLATIVE PROPOSALS.

Manufacturing 98

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 Salomon Melgen callously took advantage of patients who came to him fearing blindness,” said a DOJ news release after Melgen was sentenced in 2018. We got it just in time.”

Government 52

Government Insurance Patients Clinic 52