SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections. As a result, the patient received 2.5

FDA 40

FDA Compliance Licensing World Health 40

Bill of Health

APRIL 4, 2024

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years. Sectoral US Laws In the U.S.,

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FDA Regulatory Compliance Malpractice Health Insurance 282

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Healthcare IT News - Telehealth

DECEMBER 16, 2020

The virtual trial, to be sure, is not a new concept: One team of researchers counted more than 1,100 trials listed on ClinicalTrials.gov employing connected digital products for remote data collection in both 2017 and 2018, the organization observed. ” The FDA is hinting that some of these changes could be here to stay.

COVID-19 207

COVID-19 Hospitals Doctors Health Insurance 207

SQA

JULY 8, 2022

It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products. The guide emphasizes the effect that cryopreservation and recovery may have on cell viability and cell function.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

Hall Render

JANUARY 28, 2022

FDA halts use of antibody drugs that don’t work vs. omicron. Where Hospital Price Transparency Compliance Is Lagging. FDA finalizes two guidances on including patient perspectives in medtech clinical trials. Florida health officials face hurdles with limited supply of monoclonal antibody from government.

Nursing Homes 40

Nursing Homes COVID-19 US Department of Health and Human Services Nurses 40

Drug & Device Law

SEPTEMBER 21, 2023

The parties’ contract required the supplier to deliver components that “meet FDA standards for medical devices.” The manufacturer claimed that the supplier breached the contract when it delivered components that, according to the manufacturer, violated the FDA’s Current Good Manufacturing Practices (CGMP) regulations. Ohio 2023).

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FDA Governance Compliance 59

Drug & Device Law

DECEMBER 29, 2023

2023) (federal government may unilaterally obtain dismissal of FCA claims, and calling the constitutionality of the FCA’s private enforcement mechanism into question) ( here ); Quishenberry v. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Polansky v. 3d 239 (Cal.

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FDA US Department of Health and Human Services COVID-19 Informed Consent 105

Drug & Device Law

MARCH 19, 2024

Plaintiff’s primary allegation is that the clips have a migration rate higher than what was reported to the FDA. Since the clips are PMA, the first prong is met—PMA devices have specific FDA requirements. Plaintiff did not allege that the design of the clips deviated from the FDA approved design.

FDA 52

FDA Fraud Doctors Governance 52

Drug & Device Law

JULY 26, 2023

Hrymoc has a lot of “one-off” flavor about it, as it was tried under North Carolina law in late 2017. 2018), holding (as discussed here ) that New Jersey multi-county mass-tort litigation will henceforth be governed exclusively by New Jersey law, no matter where the plaintiff resided. 3d 503, 523 (N.J. See Winebarger v.

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Compliance FDA Licensing Governance 52