FDA Law Blog

SEPTEMBER 22, 2024

Prior to February 2, 2026, FDA also said that it does not intend to enforce complaint requirements under 21 CFR 820.198 for developers that are already in compliance with the complaint requirements under ISO 13485. SCF : LDT, unmet need within an integrated healthcare system. SCH : LDT, approved by NYS CLEP.

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FDA Law Blog

OCTOBER 6, 2023

The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. The phase out period applies to LDTs currently on the market in reliance on FDA’s enforcement discretion policy (“affected laboratories”). and what steps could be taken to mitigate those consequences.”

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FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders.

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Rocket Matter

AUGUST 22, 2024

Let’s discuss the legality of eSignatures, their enforceability, and how lawyers can leverage them effectively within their practice while maintaining compliance. Therefore, it's advisable to consult with local legal counsel to ensure compliance with specific state requirements. Healthcare Documents. Human Resources Documents.

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FDA Law Blog

JUNE 15, 2022

The hospitals argued that the profits helped them offset the considerable costs of providing healthcare to the uninsured and underinsured in low-income and rural communities, something that Congress was well aware of and intended when it passed the Medicare Prescription Drug, Im­provement, and Modernization Act in 2003. See 42 U.S.C.

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The Process Street

JANUARY 1, 2024

Agile QMS An agile QMS involves the implementation of software(s) to help encourage company-wide transparency and adaptability, whilst maintaining compliance with ISO, or any other international quality standard. QMS software: Benefits of being agile Implementing an agile QMS software has its many benefits, including: 1.

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The Process Street

AUGUST 20, 2021

How to Write an Actionable Policy and Procedure Template (ISO Compliant!). Agile ISO: How to Combine Compliance with Rapid Process Improvement. Standard operating procedures are important in all industries but particularly valued within healthcare. ISO-9000 Marketing Procedures. What is a Quality Management System?

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ClimateChange-ClimateLaw

AUGUST 22, 2022

The bill also has healthcare and prescription drug provisions, makes tax code changes unrelated to climate and energy, and guarantees federal land on- and offshore for oil and gas drilling.) Local governments with “jurisdiction over a port authority or a port” are eligible to apply for funding.

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ALPS

MARCH 8, 2022

It requires compliance with NIST framework requirements and makes once optional inspections mandatory. In addition, Federal Hearings are also underway to update the Federal Information Security Management Act (FISMA) policies. You can find more details on these changes in this blog post. reasonable?steps as a result of Log4j,?or

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FDA Law Blog

MAY 5, 2024

Former DEA Administrators and National Drug Policy Directors asserted that the science demonstrating marijuana’s high addictive potential, its lack of accepted medical use, and rescheduling impact on prosecuting drug trafficking organizations required marijuana to remain in schedule I. 21 U.S.C. §

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FDA Law Blog

AUGUST 21, 2023

This begs the question of whether these courts, and other courts looking at other state law claims, are actually undermining FDA’s authority to determine whether a drug can be used safely and effectively under its proposed conditions of use. A recent state law failure-to-warn case in the SDNY makes that very point. And indeed, after Pliva v.

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JURIST

JANUARY 7, 2022

The US Supreme Court heard oral arguments Friday concerning whether agencies under the Biden administration had the authority to require large employers and medical care facilities that participate in Medicare and Medicaid to mandate employee vaccinations. The first case, National Federation of Independent Businesses (NFIB) v.

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SCOTUSBlog

JANUARY 16, 2025

Troubled by the industrys high rates of injury, death, and use of performance-enhancing drugs, Congress created a private, nonprofit corporation called the Horseracing Integrity and Safety Authority and authorized it to issue nationwide safety and anti-doping rules, monitor state industries for compliance, and sanction or sue violators.

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SCOTUSBlog

JANUARY 6, 2022

Share With over 100,000 Americans hospitalized for COVID-19 as a result of the highly contagious Omicron variant, the Supreme Court will hear oral argument Friday in two sets of challenges to the Biden administration’s authority to take action to combat the pandemic. In the first case, National Federation of Independent Business v.

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Above The Law

MARCH 26, 2025

When broken down by appointing president when senior judges are removed the balance is as follows: These statistics are helpful in thinking about the district court judges who issued these injunctions and helps inform role politics may play not only in creating the policies that led to these cases, but potentially in the case dispositions as well.

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The Estrin Report

MARCH 16, 2025

.” The Legal Landscape Now Whether you l ove him, hate him , or fall somewhere in between, t here is no denying that Trumps policies are reshaping the industry in ways that will be felt for years. These efforts representing a more just and representative legal system, are now considered violations of presidential policy.

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