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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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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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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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Then, in 2011, the FDA issued its draft guidance of human factors and evaluations of medical devices to enhance safety and effectiveness.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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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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Healthcare It News

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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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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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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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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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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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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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

MARCH 24, 2022

Founded in 2011 by a physician and engineers from MIT and Harvard, Podimetrics developed the SmartMat — the only easy-to-use, an at-home mat that a patient steps on for 20 seconds per day. The FDA-cleared and HIPAA-compliant SmartMat are remotely monitored by Podimetrics’ in-house nurse support team.

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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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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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Bill of Health

NOVEMBER 9, 2022

In Drugs and the FDA: Safety, Efficacy, and the Public’s Trust , oncologist Mikkael A. Sekeres centers his narrative on the controversial 2011 Avastin hearings , in which the FDA reconsidered and ultimately withdrew the breast cancer indication for Genentech’s Avastin drug.

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SQA

JUNE 3, 2024

United States Food and Drug Administration (FDA) Regulations and Guidances FDA Reports on Good Guidance Practices, 03 January 2024 In 2011, FDA issued a report entitled “Food and Drug Administration Report on Good Guidance Practices: Improving Efficiency and Transparency.”

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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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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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HIPAA Journal

APRIL 8, 2025

The Food and Drug Administration (FDA) was given greater authority over medical device cybersecurity and is now assessing the cybersecurity of medical devices when reviewing premarket submissions. The patient monitor was cleared by the FDA in 2011, and the backdoor had been present for more than 13 years before it was detected.

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Drug & Device Law

FEBRUARY 22, 2024

The history of litigation over a June 2009 to March 2012 shortage of a drug called Fabrazyme, which was at the time the only FDA-approved drug to treat a nasty thing called Fabry’s disease, helps to explain our view. We do not even need to call out the emphasis that plaintiff lawyers place on FDA approval when it suits them.

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Drug & Device Law

FEBRUARY 19, 2024

For both prescription drugs and medical devices, FDA regulations provide that direct-to-patient warnings – called “adequate directions for use” – are not necessary for drugs or devices that are available only with a physician’s prescription. 6551, 6553 (FDA Feb. Such special controls are preemptive. E.g. , 76 Fed.

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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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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

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.

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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

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

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

NOVEMBER 9, 2023

In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here ), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. 552 (2011); Thompson v. FDA , 119 F. E.g. , Sorrell v.

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Drug & Device Law

NOVEMBER 2, 2023

2023), because it rejects the use of state law to impose requirements beyond those imposed by the FDA. In general, a prescription drug must be approved by the FDA before it may be sold. Qualifying compounding pharmacies do not require FDA approval to sell compounded drugs. 2011)—reads Buckman Co. 21 U.S.C. § 4th at 264.

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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

SEPTEMBER 22, 2023

As Carter recounts, starting in 1976, FDA developed the OTC Cough and Cold Monograph, 21 C.F.R. 604 (2011), and Mutual Pharmaceutical Co. Carter involved four lawsuits alleging the defendants’ cough and cold medicines (including those with phenylephrine) “do not work” and were “dangerous to children under the age of six.” at 1276.

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Drug & Device Law

AUGUST 3, 2023

604 (2011), were still playing out. To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. FDA also says so, which the Supreme Court noted in Mensing. Eleven years has also seen quite a bit of change in our space. Mensing , 564 U.S. Bartlett , 570 U.S.

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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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