Health Blawg

DECEMBER 26, 2017

The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). FDA has done a very good job of moving the ball forward, though there is certainly room for improvement, and there is opportunity for comment on two of the three guidance documents announced.

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Dot Compliance

DECEMBER 7, 2022

Dot Compliance eQMS Essential Elements 5. Ensuring Compliance with ISO 9001, EU MDR, FDA & More 6. To comply with FDA, EU MDR, and ISO regulatory requirements and lower audit risks and outcomes, more and more firms are relying on a QMS. Quality Management Systems, ISO 9001:2015. The Bottom Line. QMS Timeline.

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Dot Compliance

SEPTEMBER 30, 2022

It focuses on specific persons and processes involved in the production of goods and stops them from straying from quality standards like FDA 21 CFR Part 11, ISO and ICH Q10. Prior to ISO 9001:2015 , the standard for Quality Management Systems (QMS) was ISO 9001:2005. For cGMP compliance, the FDA audits authorized drug manufacturers.

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Dot Compliance

NOVEMBER 21, 2022

To find out the benchmark for satisfying global standards of Quality Management System, consult ISO 9001:2015 or ISO 13485:2016. Companies must have a strong quality management system and incorporate risk management to ensure compliance with GMP requirements established by regulatory bodies in order to aim for such high-quality products.

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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. Dot Compliance and Medical Device Validation. Contact Dot Compliance.

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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. Dot Compliance and Medical Device Validation. Contact Dot Compliance.

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Bill of Health

AUGUST 28, 2024

In 2015, we realized that age is a universal feature that every organism has, and started building deep learning models trained to predict age and other features. I think that regardless of how ambitious you are, you need to play by the FDA rules and ensure complete compliance with the established clinical pathways.

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SQA

SEPTEMBER 2, 2022

With the previous version of the Guide dating back to 2015, it was clear that a substantial overhaul of the text would be necessary to incorporate the technical progress and new policies that have been adopted in the intervening years. ISPE Good Practice Guide: Critical Utilities GMP Compliance.

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FDA COVID-19 Nursing Homes Compliance 91

HIPAA Journal

JANUARY 23, 2024

Carreyrou published the story in 2015 that revealed the company was using third-party technology rather than its own, as its own technology was inefficient. The FDA launched an investigation into Theranos that found that the allegations in Carreyrou’s article were correct.

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HIT Consultant

MAY 9, 2022

With mountains of paperwork generated every year, achieving complete patient privacy and 100 percent compliance can be difficult. PDF security features like encryption and redaction can help healthcare organizations achieve greater levels of compliance. The PDF format also integrates easily into EHR platforms.

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SQA

JUNE 10, 2021

Commission in March 2015 after the publication, in December 2014, of the Q3D Guideline on Elemental Impurities (EI) by the International Council for Harmonization (ICH). As such, manufacturers and importers that have already submitted their applications to CDSCO may continue marketing their devices in India as they prepare for compliance.

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COVID-19 FDA COVID-19 Vaccine Compliance 52

Verisys

NOVEMBER 14, 2023

Proven software and technology which continuously monitors these sources will ensure that your healthcare organization is in compliance at all times. With thousands of federal and state sources to screen for debarments, sanctions, exclusions, and disciplinary actions, manual monitoring of your provider population is virtually impossible.

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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. These products are widely used by Canadians.

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FDA Compliance Licensing World Health 40

Exeed Regulatory Compliance

MARCH 5, 2020

FDA Guidance on EUA, Jan 2017 *Notes: Section 564 as in the Food, Drug and Cosmetic (FD&C Act); PAHPRA refers to the Pandemic and All-Hazards Preparedness Reauthorization Act of 2015 One area of current concern is the lack of diagnostic testing capability in the US to rapidly detect and confirm new cases.

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US Department of Health and Human Services FDA Public Health COVID-19 52

Verisys

JANUARY 18, 2022

Proven software and technology which continuously monitors these sources will ensure that your healthcare organization is in compliance at all times. Food and Drug Administration (FDA). ISO 9001:2015 (quality management). Verisys’ owned and maintained Fraud Abuse Control Information System (FACIS) is a provider data supersource.

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Licensing Medicaid Medicaid Governance 52

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.

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

Healthcare IT News - Telehealth

DECEMBER 16, 2020

In March, as states were issuing stay-at-home orders, the FDA published pandemic-specific guidance for trial sponsors, institutional review boards and investigators on how to ensure the safety of their trial participants and reduce risks to trial integrity, while sustaining compliance with good clinical practice.”

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SQA

AUGUST 2, 2021

ISO5356-1:2015, Anesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets. ISO 17510:2015, Medical devices – Sleep apnea breathing therapy – Masks and application accessories. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden.

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FDA COVID-19 Pharmaceutical Industry Hospitals 83

Hall Render

DECEMBER 29, 2023

Here’s how to find quality care CEOs turn attention from recovery to growth ARKANSAS Statistics show many northern Arkansas locations considered maternity care deserts How broadband expansion is bolstering rural healthcare Arkansas leaders work to close gap between medical school graduates and in-state residencies Program in south Arkansas provides (..)

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Nursing Homes US Department of Health and Human Services COVID-19 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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Drug & Device Law

AUGUST 8, 2022

So if compliance with an industry standard is a defense, this plaintiff went a step further and sued the organizations that created the standards. 2015 WL 6393869 (S.D. 21, 2015): Mississippi does not recognize any cause of action against a voluntary non-profit trade association like TMA. . . . [T]he Big Dog Treestands, Inc.

Doctors 52

Doctors Fraud Licensing Compliance 52

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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FDA Public Health Federal Policy Doctors 116

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Mensing , 564 U.S. Mensing , 564 U.S. Lohr , 518 U.S.

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

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. 600.5805(2), (12).

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Drug & Device Law

SEPTEMBER 12, 2022

The plaintiffs in Pfaff , who opted out of the settlement, had originally brought suit in California federal court back in 2015. Relying on [that division’s] report, [the FDA division with direct responsibility for this dermatologic drug] reached the same conclusion regarding the addition of the depression warning. T]he FDA responded.

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Drug & Device Law

OCTOBER 27, 2022

640.65, an FDA biologics regulation that requires entities that collect blood via a particular method to establish “donor identification system[s]” that “positively identifies each donor and relates such donor directly to his blood and its components as well as to his accumulated records and laboratory data.”. 2015); Otis-Wisher v.

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FDA Licensing Compliance 59

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. 25, 2023), is one we have been talking about for a long time.

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Drug & Device Law

DECEMBER 6, 2022

According to the FDA, nothing, and that’s why the court dismissed the putative class action in Beasley v. As it turns out, thanks to very specific language from both the FDA and Congress, neither could the presence of PHOs before 2018. Like with drugs, foods regulated by the FDA cannot be “adulterated.” Tootsie Roll Indus.

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FDA Compliance Governance 59

Drug & Device Law

JULY 26, 2023

In these states, product liability claims are brought as negligence actions based on the reasonableness of a defendant’s conduct, and a defendant’s compliance with applicable governmental standards is typically relevant evidence. 2015 WL 5567578, at *6-7 (W.D.N.C. Hrymoc , 2023 WL 4714042, at *12-13. See Winebarger v. Lohr , 518 U.S.

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