2011, FDA and Public Health - Health Care Compliance Brief

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

FEBRUARY 15, 2023

” The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA. ” The requirements for providers (e.g.,

US Department of Health and Human Services

US Department of Health and Human Services FDA COVID-19 World Health

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

trillion spending package, which consists of all 12 fiscal year (FY) 2023 appropriations bills and funds the federal government through September 30, 2023, provides additional assistance to Ukraine, and makes numerous health care policy changes. 117-164 ) (the “Act”)—an approximately $1.7

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. An overview of the FY 2022 funding bill and a summary of its health care-related provisions can be found below.

COVID-19

COVID-19 Medicare Medicare FDA

Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

Drug & Device Law

DECEMBER 12, 2022

223, 231-33 (2011), holding that the Vaccine Act preempted all design defect claims asserted by claimants who rejected Vaccine Act awards and sought to litigate their claims instead. The Supreme Court did its part in Bruesewitz v. Wyeth LLC , 562 U.S. Now comes DeCostanzo v. at 226 (footnote and quotation marks omitted). 300aa-22(b)(1).

FDA

FDA Public Health Fraud Hospitals

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

FDA

FDA US Department of Health and Human Services COVID-19 Informed Consent

Generic Causation Experts Excluded In Sweeping Ruling From The Acetaminophen MDL

Drug & Device Law

DECEMBER 28, 2023

In addition, although we generally do not speak of judges, we note that the judge overseeing this MDL took the federal bench in 1994—a year after Daubert —and had a, shall we say, interesting history with issues of preemption and the FDA over the first year or so of the MDL. 2011), which might have been our third example above.

FDA

FDA World Health Public Health

Fourth Circuit Upholds Restrictions on Plaintiff Lawyer Advertising in West Virginia

Drug & Device Law

MAY 10, 2022

The second part of the Act is likewise geared toward preventing confusion or misleading the public but by requiring certain disclosures accompany all ads concerning drugs and devices approved by the FDA: Such advertisements must include the warning: “Do not stop taking a prescribed medication without first consulting with your doctor.

Governance

Governance FDA Doctors Public Health

Preemption and OTC Drugs

Drug & Device Law

SEPTEMBER 22, 2023

Constitution’s Supremacy Clause, it strikes a balance between state and federal power on issues of public health and safety, and raises questions about whether our country’s approach to regulation and litigation makes sense for pharmaceuticals and medical devices (spoiler alert: it doesn’t). 604 (2011), and Mutual Pharmaceutical Co.

FDA

FDA Public Health

Another Attack On A Contraceptive Is Dismissed (For Now)

Drug & Device Law

OCTOBER 7, 2022

One particular “permanent” implantable contraceptive device has been the subject of litigation for years, even though it was approved by FDA as a class III device. (Our Plaintiff had the device implanted in 2011 and explanted more than seven years later, apparently not because of any symptoms or known injury. 2022 WL 4536240, *1.

FDA

FDA Fraud Doctors Public Health

Stretching Specific Personal Jurisdiction And Shrinking Preemption At The Pleadings Stage

Drug & Device Law

MARCH 2, 2023

Commentators beyond this Blog have described how this bent affects contraceptive choice and public health. As to one defendant, the court looked solely to whether plaintiffs’ claims “arise out of or relate to” contacts with Georgia that began in 2019, even though the implants were in 2011 to 2013. 2023 WL 2111346, *6.

FDA

FDA Public Health

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. IMS Health, Inc. , Instead, the Missouri law clearly picked a side. Reagan Nat’l Adver. of Austin , 142 S.

COVID-19

COVID-19 Public Health FDA Governance

Federal Preemption of State Attempts To Ban FDA-Approved Abortion Drugs After Dobbs

Drug & Device Law

JUNE 28, 2022

Jackson Women’s Health Org. , June 24, 2022), we fully expect attempts by such states to ban FDA-approved prescription drugs that can be used to bring about abortions by chemical means. But when the FDA has approved a product, states no longer have the power to prohibit their sale or use for FDA-approved indications.

FDA

FDA Public Health Federal Policy Doctors

Health Care Compliance Brief

SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA Regulatory Surveillance Summary 6 | Monthly Update 2021

Trending Sources

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

Terrible Decision Contravenes the Vaccine Act’s Purpose and Would Gut Its Protections

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Generic Causation Experts Excluded In Sweeping Ruling From The Acetaminophen MDL

Fourth Circuit Upholds Restrictions on Plaintiff Lawyer Advertising in West Virginia

Preemption and OTC Drugs

Another Attack On A Contraceptive Is Dismissed (For Now)

Stretching Specific Personal Jurisdiction And Shrinking Preemption At The Pleadings Stage

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

Federal Preemption of State Attempts To Ban FDA-Approved Abortion Drugs After Dobbs

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