Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Part 820 ), unless they fall under an exemption.

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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

FEBRUARY 7, 2023

Food and Drug Administration (“FDA”) released an updated Mifepristone Risk Evaluation and Mitigation Strategy (the “Mifepristone REMS Program”), which reverses the requirement that the drug be dispensed directly to a patient by certified prescriber in a clinic or a medical office (the “in-person dispensing requirement”).

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Healthcare Law Blog

JANUARY 12, 2022

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Guidance Overview. I distribute products under an EUA, what do I do now?

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Hall Render

JULY 29, 2022

Food and Drug Administration (“FDA”) issued guidance (“Guidance”) regarding the “Importation of Prescription Drugs” final rule (the “Final Rule”), which became effective November 30, 2020. SIPs are reviewed and authorized by the FDA and managed by States or Indian Tribes (“SIP Sponsors”). In May 2022, the U.S. Brief Discussion.

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Hall Render

JANUARY 11, 2023

The Tool is a result of collaborative efforts between the FTC, HHS Office for Civil Rights (“OCR”), HHS Office of the National Coordinator for Health Information Technology (“ONC”) and the Food and Drug Administration (“FDA”). Your primary Hall Render contact. Regulatory Landscape.

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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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MedTrainer

FEBRUARY 19, 2024

Exposure incidents: Unanticipated events that involve contact with blood or other bodily fluids that can potentially cause harm. Why Incident Reporting is Essential Incident reporting is essential to maintain a healthcare organization’s compliance with state and federal regulations. Contact us to learn more.

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Innovaare Compliance

OCTOBER 6, 2022

Adult vaccine recommended by ACIP is a covered Part D drug when licensed by the US Food and Drug Administration (FDA) under the Public Health Service Act for use by adult populations and administered in accordance with recommendations of ACIP. or Contact Us. appeared first on Inovaare.

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Healthcare Law Today

JANUARY 25, 2023

Food & Drug Administration (FDA or Agency) the authority to order a mandatory recall of a cosmetic product and to suspend a facility registration if FDA determines there are serious adverse health concerns. distribution must register with the FDA no later than one year after the enactment of MoCRA, which is December 29, 2023.

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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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Hall Render

OCTOBER 18, 2022

Defendant pharmaceutical manufacturers applied for and received approval from the FDA to manufacture Gamunex at a facility converted for that purpose. FDA regulations require current Good Manufacturing Practices [cGMP] to be met or the drug shall be deemed adulterated and prohibited from sale. Your primary Hall Render contact.

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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. We continuously hear of infractions and warnings issued to companies for lack of regulatory compliance.

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Natalia Mazina

JUNE 26, 2023

counterfeit, unapproved, or potentially dangerous)) Notification (trading partners must notify FDA if they suspect that the product is illegitimate). The Act sets six compliance deadlines. The last one is coming up on November 27, 2023 and pertains to enhanced product tracing.

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C&M Health Law

JANUARY 25, 2023

For more information, or to better understand how the Act impacts your organization, please contact the professionals listed below, or your regular Crowell & Moring contact.

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Compliancy Group

NOVEMBER 2, 2022

The Food and Drug Administration (FDA) recognized this when they released guidance for medical device manufacturers to increase cybersecurity. Medical device manufacturers must submit a ‘Cybersecurity Bill of Materials’ during premarket reviews to the FDA for review. HIPAA compliance can help you address your security needs.

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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. With a team of compliance specialists, Inovaare provides in-depth technical expertise and compliance preparedness evaluation, guidance, and support.

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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. Dot Compliance eQMS Essential Elements. The Bottom Line. QMS Timeline.

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SQA

SEPTEMBER 2, 2022

Call for Companies to Register their Industry Single Point of Contact (i-SPOC) on Supply and Availability, 28 June 2022. All pharmaceutical companies with a centrally-or nationally-authorized medicinal product in the EU are required to register a single point of contact. ISPE Good Practice Guide: Critical Utilities GMP Compliance.

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AIHC

AUGUST 2, 2022

The monkeypox virus is spreading mostly through close, intimate contact with someone who has monkeypox. Monitoring Exposures First, educate yourself, coworkers with direct patient contact, and your patients regarding how to prevent becoming infected with this virus. These cases occurred on multiple continents.

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Total Medical Compliance Resources

MARCH 19, 2024

Agencies such as the CDC, FDA, and the ADA have issued guidance for dental offices on maintaining DUWL. Contact the manufacturer of your dental units to find out which method(s) of treatment would work best for your dental unit. It also provides documentation of compliance. Biofilm can form in any water environment.

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Hall Render

MARCH 29, 2023

It is hard to believe that spring is finally here and the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) has yet to take any enforcement action in 2023. Untitled Letters allow a company to correct the violations without any further FDA action. Practical Takeaways Letters.

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SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. After receiving complaints, ANVSA performed joint inspections with local health surveillance agencies.

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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

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. Contact us and let us know how we can help.

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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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Hall Render

JULY 14, 2023

On June 7, 2023, the Food and Drug Administration’s (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued its first Untitled Letter of the year regarding violative promotional materials for a prescription drug indicated for the treatment of endogenous hypercortisolemia (high cortisol) in adults with Cushing’s syndrome.

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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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SQA

DECEMBER 10, 2021

Brazil’s New UDI Requirements for Medical Devices: Compliance Implications for Manufacturers, 02 August 2021. UDI compliance lead times for manufacturers will depend on the risk classification of their devices: Two years for Class IV (highest risk) devices. By Laurel Hacche & Debra Cortner SQA Associates. European Commission (EC).

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SQA

OCTOBER 18, 2022

The entire shipment, which contained 435 boxes of the 25-pack, was sent to Health Canada for compliance follow-up. After this date, the CAP’s compliance team will remove non-compliant ads using targeted software, and those who continue to promote it may be referred to the MHRA for further enforcement action. Health Advance Inc.

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SQA

AUGUST 2, 2021

Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) and the United States Food and Drug Administration (FDA) released a series of policy recommendations to address the vulnerabilities in United States pharmaceutical supply chains. United States FDA – Guidances for Devices.

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SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

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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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SQA

AUGUST 8, 2023

Personal Care Products Council (PCPC) PCPC MoCRA Toolkit, May 2023 Enacted in December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents years of efforts by the Personal Care Products Council, the FDA, Congress, and other stakeholders to modernize the U.S. cosmetic regulatory framework.

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Healthcare IT News - Telehealth

AUGUST 19, 2020

"Using a patient service coordinator to schedule and contact patients to gain necessary paperwork and payments proved to be an effective workflow. Currently, there is a 96% overall compliance rate. Using the technology platform enabled all parties involved to contact patients for visits, assessments and follow-ups.

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