MedTrainer

JUNE 5, 2023

After years in limbo, USP <800> compliance will be required, effective November 1, 2023. It’s the first USP standard that’s enforceable by State Boards of Pharmacy, OSHA, and the FDA. What’s Needed for USP <800> Compliance?

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Hall Render

OCTOBER 5, 2023

Food and Drug Administration (“FDA”) finalized “ Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors ” (“Final Guidance”), following the FDA’s earlier issuance of draft guidance on the subject in July 2014. study sponsor, regulatory agencies, etc.) On August 15, 2023, the U.S.

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Exeed Regulatory Compliance

MARCH 22, 2020

Timely MDR reporting is a challenging regulatory requirement for the industry. A new FDA guidance provides much-needed relief during a pandemic. Adverse event reporting requirements are very stringent, and late reporting of such events is a routine focus of FDA inspections and subsequent warning letters.

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Dot Compliance

JUNE 16, 2022

Maintaining compliance with safety and quality standards is a significant issue in medical device manufacturing. Millions of dollars are lost by manufacturers every year due to regulatory non-compliance issues and related lawsuits. The QMS supports the manufacturers, leading to ISO confirmation and FDA compliance.

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HIT Consultant

FEBRUARY 1, 2024

The challenges and considerations for pharmaceutical influencer marketing The challenges of pharma influencer marketing include choosing the right influencers, managing risks, and ensuring compliance with ethical guidelines; some specific challenges are: Regulatory Compliance The FDA regulates some aspects of pharma marketing.

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Dot Compliance

FEBRUARY 22, 2022

FDA regulations govern what you can claim about your product and whether you can even sell it at all. For companies that manufacture drugs, biotechnology, and related products, demonstrating the safety and effectiveness of your goods to the FDA’s satisfaction has to be a top priority. What is the process for FDA drug approval?

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Exeed Regulatory Compliance

APRIL 2, 2020

Market for interconnected medical devices is projected to grow but the regulatory pathway is still evolving. A new FDA guidance offers helpful recommendations for design and premarket submission. One way to understand how FDA is thinking about regulating these devices is to review recently cleared devices.

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HIT Consultant

AUGUST 16, 2023

Accelerating the Adoption of IDMP-O to Simplify and Standardise data Assets “Fluree is a perfect fit for pharmaceutical organizations seeking to balance regulatory compliance with innovation and accelerate drug discovery, efficacy and efficiency,” said Eliud Polanco, Fluree president.

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Dot Compliance

FEBRUARY 23, 2024

Their tasks included documenting quality processes, obtaining signatures from authorized individuals, and storing documents for regulatory compliance. Choose an eQMS provider with proven life sciences industry expertise and a platform preconfigured to industry standards like FDA, ISO, and GxP.

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Exeed Regulatory Compliance

JULY 6, 2020

Let us understand how they help and how FDA plans to regulate them. In this article, we explain the FDA requirements, and guidance for face masks when they are used for a medical purpose such as diagnosis, or cure, mitigation, treatment of prevention of disease.

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MedTrainer

JULY 12, 2023

Here’s a closer look at the critical role incident management software plays in risk mitigation and compliance in healthcare environments. Read this case study to discover how one organization’s use of online incident reporting, amongst other digital compliance tools, helped to add 50 additional practice locations. Risk Mitigation.

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MedTrainer

JULY 12, 2023

Here’s a closer look at the critical role incident management software plays in risk mitigation and compliance in healthcare environments. Read this case study to discover how one organization’s use of online incident reporting, amongst other digital compliance tools, helped to add 50 additional practice locations. Risk Mitigation.

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Exeed Regulatory Compliance

JULY 10, 2020

The FDA is consistently updating its Guidance and policy for various Face Masks, Face Shields and Respirators as new information becomes available. We recently discussed the FDA’s policy for Face Masks during COVID-19. As a result, FDA has now established additional requirements for authorization of Respirators made in China.

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Exeed Regulatory Compliance

AUGUST 3, 2020

Understanding the Available Diagnostic Tests As of this writing, the FDA has authorized 187 different tests, including 154 RT-PCR molecular diagnostic tests for COVID-19. FDA allowed physicians to order one of the authorized tests if they suspected COVID-19 even when the patient did not show any symptoms. CONTACT US.

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Exeed Regulatory Compliance

FEBRUARY 25, 2020

Regulatory Breakthrough In a small step towards achieving the vision of interoperable medical devices, the FDA has recently authorized marketing of a novel software medical device using the De Novo Classification. the FDA expects for interoperable devices.

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Verisys

NOVEMBER 30, 2022

Maintaining compliance and safeguarding against fraud and abuse in today’s changing healthcare landscape can be challenging. Excluded from one means excluded from all, and the fines for non-compliance will likely be in the hundreds of thousands. OIG, SAM DEA, GSA, FDA. How many data sources is your organization monitoring?

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Dot Compliance

MARCH 17, 2022

All while keeping in mind that compliance to regulations and global standards are non-negotiable, especially in the highly regulated life science and biotech industries. Here are key points to consider when selecting a QMS solution to support your company’s compliance and growth.

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Health Care Law Brief

JUNE 2, 2022

In addition, the PHE fueled a boom in the number of direct-to-consumer (“DTC”) telehealth platforms, many of which have relied upon COVID-19 regulatory waivers to launch and operate in multiple states across the nation. How will data be used for marketing, in compliance with applicable laws, including HIPAA?

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AIHC

JUNE 14, 2023

Artificial Intelligence & Regulatory Compliance Written by Joanne Byron , BS, LPN, CCA, CHA, CHCO, CHBS, CHCM, CIFHA, CMDP, COCAS, CORCM, OHCC, ICDCT-CM/PCS This article follows Part 1 - Basics of Artificial Intelligence (AI) and Healthcare Compliance published by AIHC on June 6, 2023.

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Dot Compliance

JANUARY 4, 2022

For manufacturers the challenges of developing connected devices range from connectivity to regulatory compliance, but perhaps most important is cybersecurity. The post 2022 Life Sciences Technology Predictions appeared first on Dot Compliance.

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Dot Compliance

SEPTEMBER 11, 2022

FDA 21 CFR Part 11 is a rule that specifies how businesses that are subject to FDA regulation, such as those in the medical device, pharmaceutical, and other industries, should manage their electronic records and electronic signatures. Computer Systems That Require Compliance to 21 CFR Part 11. A wise investment, indeed.

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Healthcare IT Today

JUNE 7, 2023

Many of our concerns center on the proposed implementation timeframes associated with various concepts included in HTI-1, as well as ONC’s failure to sufficiently consider the burden compliance will place on provider organizations and health IT developers. 31, 2024, compliance timeline is unrealistic.

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Dot Compliance

APRIL 12, 2022

Then we will provide general guidelines for producing labels that will benefit your customers and meet regulatory obligations. The FDA definition of a medical device is something that diagnoses, cures, treats, or prevents a disease or health condition, or otherwise alters the structure or function of the body. US FDA Requirements.

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Healthcare IT Today

AUGUST 21, 2023

FDA’s Drug Supply Chain Security Act (DSCSA). RFID’s Potential: Improved Efficiency, Safety, and Regulatory Compliance RFID technology offers significant potential for improving efficiency and patient safety in healthcare applications.

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Exeed Regulatory Compliance

MARCH 9, 2020

Here is an update on recent FDA activities. Cybersecurity of medical devices is on FDA’s radar! Just last week, the FDA issued a safety communication about the recently identified SweynTooth family of cybersecurity vulnerabilities which may affect medical devices. Please click on the video link below.

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HIT Consultant

JULY 12, 2023

PV signal teams must balance growing workloads with maintaining regulatory compliance. Advanced cognitive computing capabilities, including machine learning (ML), boost operational performance, support greater compliance, and increase control by streamlining workflows, maximizing signal and risk physician output.

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Healthcare IT Today

JANUARY 8, 2024

It is key for pharmaceutical companies to recognize that efficiency does not override compliance, patient safety or regulatory standards. While each company successfully gained FDA approvals, the current market acceptance for prescription digital therapeutics is low and improvements will take years.

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Dot Compliance

JANUARY 14, 2022

There are many risk management regulations and compliance standards in the life sciences industry that must be followed to successfully maintain business operations and ensure the safety of staff and product users. FDA’s Safer Technologies Program (SteP) for Medical Devices. Key Risk Management Regulations. Source: [link].

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Dot Compliance

SEPTEMBER 11, 2022

The United States Food and Drug Administration (FDA) has the authority to enforce compliance with the Code of Federal Regulations , which has significant consequences if disregarded. Considering ISO 9001:2015 certifications makes sense for pharmaceutical managers given the requirement for compliance, quality, and safety.

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Exeed Regulatory Compliance

JULY 31, 2020

In a major crisis like this, it is good to know that the FDA has a special authority to quickly allow marketing of medical products that can help diagnose, mitigate or treat this highly infectious disease. If the answer is yes, then FDA may not issue an EUA.

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Exeed Regulatory Compliance

OCTOBER 26, 2020

A double-blinded, placebo-controlled, randomized clinical trial provides support for FDA approval of Remdesivir for treating COVID-19. The FDA has just approved a new antiviral drug, Remdesivir from Gilead Sciences , for treating COVID-19 patients needing acute care in a hospital. FDA is requiring additional post-market studies.

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Exeed Regulatory Compliance

MARCH 21, 2020

Industry is rapidly developing novel coronavirus diagnostic tests for emergency use authorization by the FDA. There is one piece of good news that the FDA has very rapidly approved several tests in the last 2 weeks under the Emergency Use Authorization and more are expected to follow. What’s the secret to its success?

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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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Exeed Regulatory Compliance

JULY 20, 2020

The Accuracy of Covid-19 Antibody Tests As we write this blog, the FDA has authorized 30 different antibody tests for Emergency Use. The second risk is related to the FDA Emergency Use Authorization process itself. Under normal circumstances, FDA would require a lot more data on clinical validation before approving these tests.

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Bill of Health

APRIL 4, 2024

Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.

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Health Care Law Brief

OCTOBER 27, 2021

This means that although ketamine is approved by the FDA for some medical uses, it is not specifically approved to treat depression. Regulatory Licensure. In many states, operating a ketamine clinic does not require a specific regulatory facility license. Ketamine is a Schedule III controlled substance. [4]

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Exeed Regulatory Compliance

OCTOBER 19, 2020

The FDA is now reviewing an Emergency Use Authorization of this treatment, which will make it available for broader use. In the first video of our series, we are discussing the antibody “cocktail” from Regeneron that shows potential for an early intervention with symptomatic COVID-19 patients.

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