Dot Compliance

FEBRUARY 8, 2022

Regulatory bodies, namely the FDA and IMDRF, have issued regulations that apply to given software applications used on mobile applications and general-purpose platforms alike. However, ongoing innovations create new challenges on a regular basis for developers.

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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. Typically, validation is carried out by a series of tests and inspections.

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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. Typically, validation is carried out by a series of tests and inspections.

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Health Populi

MAY 20, 2024

Combatting the opioid overdose epidemic has some good news emerging from the medicines sector, with per capita prescribing of opioids down 67% since its apex in 2011. The FDA does not test compounded drugs for efficacy or safety, but allows companies to produce them if there is a shortage of FDA-approved versions of the product.

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HIT Consultant

JUNE 27, 2023

New research from Mayo Clinic Proceedings found that 63% of physicians report at least one symptom of burnout, a drastic increase from 46% in 2011. A digital solution should also offer personalized integration with ongoing support, feature enhancements and updates.

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The Digital Health Corner

NOVEMBER 29, 2023

The objective of my blog, which began in 2011, was and remains educating the reader (clinicians, healthcare IT community, patients and caregivers, and other healthcare stakeholders about digital health technology and how it is relevant to the changing healthcare environment. It has been a long time since my last post of 2018.

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The Health Law Firm

JUNE 1, 2012

The prescriptions impacted by this recall include all sterile human and veterinary compounded prescriptions distributed by Franck’s Pharmacy from November 21, 2011 to May 21, 2012. Recall Based on FDA Findings of Fungal Growth in Pharmacy's Clean Room. To see the recall click here.

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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.

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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. 3] Over several years, the “donut hole” or coverage gap for Part D has been closing since 2011. [4] Rebates from the selected drugs may change.

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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.

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Healthcare IT News - Telehealth

MARCH 18, 2022

Companies like Pear Therapeutics, Limbix, Applied VR and Click Therapeutics are treating people with clinically validated and FDA-approved (or pending) digital interventions. While the growth of telehealth platforms has been substantial, a more exciting area of investment in mental health is in digital therapeutics.

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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.,

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HIT Consultant

JULY 24, 2023

Then, in 2011, the FDA issued its draft guidance of human factors and evaluations of medical devices to enhance safety and effectiveness. It is not a stretch to say human factors is still in its infancy in medicine.

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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.

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Health Law Advisor

APRIL 26, 2023

FDA have called into question the U.S. Food and Drug Administration’s (“FDA’s”) scientific review process to approve new drug applications. The Texas District Court ruling had the effect of suspending the FDA’s approval of mifepristone. FDA , the FDA moved the U.S. While the U.S.

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Healthcare Law Blog

JANUARY 20, 2023

The Food and Drug Administration (the “FDA”) has approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program, increasing the accessibility of mifepristone for patients with a prescription. [1] Supreme Court held in Dobbs v. Jackson Women’s Health Organization that the U.S.

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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. We’re also improving quality of life for nursing home residents. We’ve already reaped rewards from our quality improvement work. percent.

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HIT Consultant

FEBRUARY 6, 2023

For example, only 3% of the 2,728 US digital health deals since 2011 have focused on women’s health. Education and conversation around women’s healthcare are evolving, however, women’s health technology is still, by far, an emerging industry.

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C&M Health Law

JANUARY 25, 2023

The Act’s health care offset title includes Section 4163, which extends the 2% Budget Control Act of 2011 Medicare sequester for six months into FY 2032 and lowers the payment reduction percentages in FYs 2030 and 2031. FDA is required to finalize this guidance no later than one year after the public comment for the draft guidance ends.

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Health Law Advisor

MAY 3, 2022

We have just gone through an extraordinary two years where, in unprecedented fashion, FDA’s inspection process was essentially shut down. Further, from a warning letter standpoint, without inspection data, FDA focused in other compliance realms than it typically might. Just a short while ago FDA recommenced inspections.

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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. On Tuesday, March 15, 2022, President Biden signed into law the Consolidated Appropriations Act of 2022 ( H.R.

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Drug & Device Law

MAY 19, 2023

The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying say “no” and trying to ban that same FDA-approved drug. T]he growing market for mifepristone. . .

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Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. 604, 624-25 (2011) (FDCA preemption case). Back in 2008, the United States Supreme Court held, in Riegel v. Medtronic, Inc. , E.g. , Kindred Nursing Centers Ltd. Partnership v. at 1206.

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Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

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Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

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Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications.

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Drug & Device Law

JUNE 28, 2022

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. Jackson Women’s Health Org. ,

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Drug & Device Law

SEPTEMBER 19, 2022

604 (2011) , failure-to-warn claims targeting a pharmaceutical are preempted unless the manufacturer could have provisionally changed its warning label without prior FDA approval under the “changes being effected” (“CBE”) provision codified at 21 C.F.R. Under Wyeth v. Levine, 555 U.S. 555 (2009) , and PLIVA, Inc. Mensing, 564 U.S.

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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. . §§349-50, 300aa-22(b)(1). 300aa-22(c).

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Drug & Device Law

NOVEMBER 10, 2023

Indeed, the FDA stated, in connection with the same drug recalls that the Valsartan plaintiffs use to define their classes, 2023 WL 1818922, at *20-21: [These] medicines. . . FDA, “ Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications ” (Aug. 18, 2019) (emphasis added). 2023 WL 1818922, at *36.

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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.

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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.

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Drug & Device Law

JANUARY 8, 2024

The Acetaminophen MDL was a classic example, where the FDA had independently looked at the science no fewer than six times (in 2014, 2015, 2016, 2017, and 2022, and 2023) and each time concluded that the science did not justify any warning. Ohio 2011), aff’d , 567 F. Doyle , 2015 WL 4528759, at *21 (Mag. 2d 712, 743 (N.D. 359 (6th Cir.

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Drug & Device Law

AUGUST 2, 2022

223 (2011), product liability litigation over childhood vaccines is rare but not extinct. The Act expressly preempts design defect claims where the vaccine is accompanied by a proper warning (which is presumed if it complies with FDA requirements). Since the Supreme Court decided Bruesewitz v. Wyeth LLC , 562 U.S. Sanofi Pasteur Inc.

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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.

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Drug & Device Law

JUNE 6, 2022

The prescriber] provided explicit, uncontroverted testimony that, even when provided with the most current research and FDA mandated warnings, as well as the information found in [defendant’s] updated. . . 2011) (no causation where “at the time of her deposition ? May 23, 2011) (no causation where prescriber “testified. . .

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Drug & Device Law

JANUARY 15, 2024

We have discussed how exclusion of FDA compliance in pelvic mesh cases, based on a false equivalence between preemption and evidentiary admissibility, has hampered the defense in that litigation. In state court, Creazzo remains binding precedent. 3d 1245 (N.J. See Covell v. Bell Sports, Inc. , 3d 357, 366 (3d Cir.

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