2011 and FDA - Health Care Compliance Brief

Federal Court of Appeals Panel Issues Ruling in Litigation Challenging FDA Approval of Mifepristone

Hall Render

AUGUST 31, 2023

Food & Drug Administration (“FDA”) approval and regulation of mifepristone (brand name Mifeprex), a drug used in medically induced abortions. The panel vacated in part and affirmed in part a decision by a District Court judge in Texas that would have suspended the FDA’s approval of mifepristone. Jackson Women’s Health.

FDA

FDA COVID-19

Understanding the 2025 Medicare Part D Re-design: What You Need to Know

Innovaare Compliance

JANUARY 15, 2024

6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. Contact Inovaare for expert guidance on navigating these transformations. Rebates from the selected drugs may change.

Medicare

Medicare Medicare Compliance FDA

QMS 101: Medical Device Validation

Dot Compliance

OCTOBER 10, 2022

When the product itself cannot be examined, process validation guarantees that the procedures used to make the device comply with FDA rules. From 2011 to 2015, the top FDA warning letter citation for design controls was design validation. Contact Dot Compliance. Does the device operate in the user’s surroundings?

FDA

FDA Compliance

QMS 101: Medical Device Validation

Dot Compliance

OCTOBER 10, 2022

When the product itself cannot be examined, process validation guarantees that the procedures used to make the device comply with FDA rules. From 2011 to 2015, the top FDA warning letter citation for design controls was design validation. Contact Dot Compliance. Does the device operate in the user’s surroundings?

FDA

FDA Compliance

Ensuring Safety and Quality in America’s Nursing Homes

CMS.gov

APRIL 15, 2019

Too often, residents with dementia-related psychosis have been deemed to be unruly or difficult, and have been given antipsychotic sedative drugs in contravention of FDA guidelines. If you need outside help, you can use our website to find the contact information for your state’s SSA and Long-Term Care Ombudsman.

Nursing Homes

Nursing Homes Nurses Compliance Medicare

SQA Regulatory Surveillance Summary 6 | Monthly Update 2021

SQA

DECEMBER 10, 2021

Pilot Program: EMA-FDA Parallel Scientific Advice for Hybrid/Complex Generic Products – General Principles, 15 September 2021. The agencies conduct PSA meetings under the auspices of the confidentiality arrangement between the European Commission, the EMA, and the FDA. European Medicines Agency (EMA). The EMA and the U.S.

FDA

FDA Compliance Public Health Hospitals

FDA Oversight of AI Software Developed by Health Care Providers

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA

FDA Licensing Hospitals Medicaid

President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

C&M Health Law

JANUARY 25, 2023

For more information, or to better understand how the Act impacts your organization, please contact the professionals listed below, or your regular Crowell & Moring contact. Triggered by enactment of the American Rescue Plan Act of 2021, the 4% cut to the Medicare program would have taken effect in January 2023.

Medicaid

Medicaid Medicaid Medicare Medicare

President Signs FY 2022 Funding Bill into Law with 340B, Telehealth and Other Health Care Provisions

Hall Render

MARCH 16, 2022

The measure includes funding for health care-related agencies, such as HHS, CMS, HRSA and the FDA, as well as several health care policy riders and provisions that address issues like 340B and telehealth waivers. Your primary Hall Render contact. 2471 ) that funds the federal government for the remainder of FY 2022.

COVID-19

COVID-19 Medicare Medicare FDA

We Said It Before; We’ll Say It Again – Drug/Device Companies Should Join PLAC

Drug & Device Law

FEBRUARY 25, 2022

We return to a theme we’ve repeated twice before, in 2011 and in 2014 – that in addition to industry-specific groups, manufacturers of prescription medical products should definitely consider joining the Product Liability Advisory Council (“PLAC”). allegations of failure to report adverse events to the FDA. The appeal remains pending.

FDA

Albrecht Progeny – Fosamax Femur Fracture Claims Preempted

Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? The manufacturer informed the FDA, but no evidence then established that risk as anything more than hypothetical.

FDA

FDA Governance

Not An Early April Fools’ Day Joke: State Still Pushes Its Dumb Ivermectin Law

Drug & Device Law

MARCH 30, 2023

The side it picked was against public health and the authority of FDA, which is charged by Congress with protecting public health. To initiate contact would create a risk of a range of disciplinary actions against the pharmacist. Instead, the Missouri law clearly picked a side. IMS Health, Inc. , Reagan Nat’l Adver.

COVID-19

COVID-19 Public Health FDA Governance

Stretching Specific Personal Jurisdiction And Shrinking Preemption At The Pleadings Stage

Drug & Device Law

MARCH 2, 2023

Plaintiffs alleged that they had these contraceptive devices implanted between 2011 and 2013 (presumably in Georgia), and later suffered some combination of a wide range of symptoms that they attributed to “migration” of the device. But BMS and Walden both hold that a plaintiff’s actions cannot qualify as a defendant’s contacts.

FDA

FDA Public Health

Health Care Compliance Brief

Federal Court of Appeals Panel Issues Ruling in Litigation Challenging FDA Approval of Mifepristone

Understanding the 2025 Medicare Part D Re-design: What You Need to Know

Trending Sources

QMS 101: Medical Device Validation

QMS 101: Medical Device Validation

Ensuring Safety and Quality in America’s Nursing Homes

SQA Regulatory Surveillance Summary 6 | Monthly Update 2021

FDA Oversight of AI Software Developed by Health Care Providers

President Biden Signs End-of-Year Legislation Including Telehealth, Medicare & Medicaid, Mental Health, Pandemic Preparedness, and Other Health Care Provisions

President Signs FY 2022 Funding Bill into Law with 340B, Telehealth and Other Health Care Provisions

We Said It Before; We’ll Say It Again – Drug/Device Companies Should Join PLAC

Albrecht Progeny – Fosamax Femur Fracture Claims Preempted

Not An Early April Fools’ Day Joke: State Still Pushes Its Dumb Ivermectin Law

Stretching Specific Personal Jurisdiction And Shrinking Preemption At The Pleadings Stage

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