FDA Law

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. products intended for medical purposes).

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FDA Law

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). Throughout the SIUU Guidance, FDA refers to studies and analyses , suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial.

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FDA Law

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here.

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FDA Law

AUGUST 4, 2022

That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability. Pfizer emphasized to OIG that it would not offer this copay assistance as part of any advertisement or solicitation for tafamidis.

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FDA Law

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

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FDA Law

JANUARY 12, 2025

As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

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FDA Law

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements.

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FDA Law

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. products intended for medical purposes).

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FDA Law

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. UNDERSTAND the importance of cGMPs to the post-approval regulatory process.

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FDA Law

JULY 8, 2024

According to the dissent, where the government is the claimant, it concerns a public right. As the dissent points out, the federal government has operated for decades on the assumption that many disputes can be adjudicated by ALJs. So the SEC has the option of retrying Jarkesy in a district court.

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FDA Law

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. By David B. Clissold & Sara W.

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FDA Law

MAY 30, 2024

The 340B statute requires drug manufacturers to sell certain drugs at discounted ceiling prices to covered entities, which are defined by statute to include certain types of safety net hospitals, health centers, and clinics receiving federal grants. We have blogged about this controversy in previous posts (see e.g., here and here ).

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FDA Law

OCTOBER 25, 2021

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

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FDA Law

AUGUST 29, 2021

The federal government does its own version of rebranding with each change in administration. clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g., Walsh & JP Ellison — Companies often use rebranding to reposition and refocus their business.

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FDA Law

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). Javitt & Allyson B.

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FDA Law

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

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FDA Law

MARCH 1, 2023

Before discussing the 2023 paper, it’s important to know that the QMM Program is separate from the Quality Metrics Program , which we previously blogged about here , here , and here. On November 2, 2022, the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee held a meeting on CDER’s QMM Program.

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FDA Law

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Changes from the 2016 Guidance.

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FDA Law

JANUARY 6, 2022

220 and was described on HP&M’s blog here. In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. §

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FDA Law

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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Manufacturing Government Referral Provider 52

FDA Law

OCTOBER 7, 2024

FDA has civil money penalty authority relating to clinical trials, devices, foods, drugs, and tobacco; although with the exception of tobacco, FDA has not recently exercised that authority with regularity. The propriety of nationwide injunctions has been discussed by legal scholars, judges and Justices in recent years.

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FDA Law

JUNE 27, 2024

The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. By Larry K. District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” 21 U.S.C. § 823(g)(1)(B), (D).

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FDA Law

JANUARY 5, 2023

Another is the June 2022 Letter to Health Care Providers about a cybersecurity vulnerability affecting Illumina medical devices for clinical diagnostic use in sequencing a person’s DNA or testing for various genetic conditions. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.

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FDA Law

JANUARY 6, 2022

220 and was described on HP&M’s blog here. In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. EKRA is codified at 18 U.S.C. § 18 U.S.C. §

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FDA Law

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. In short, Voluntary Consensus Standards (VCS) are intended to be exactly what the name conveys – standards that are adopted by consensus and are not mandatory (not legal or regulatory requirements).

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FDA Law

JUNE 16, 2023

We expect the Minnesota law to face Commerce Clause, vagueness, and possibly other constitutional challenges, similar to those brought against a generic price gouging prohibition in Maryland that was struck down by the Fourth Circuit in 2018 (see our post here ).

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FDA Law

APRIL 30, 2021

Government Accountability Office report here ). This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data. As we perused the bills, we sorted them into three categories: the Good, the Bad, and the Ugly.

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FDA Law

APRIL 30, 2021

Government Accountability Office report here ). This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data. As we perused the bills, we sorted them into three categories: the Good, the Bad, and the Ugly.

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ABIM

JUNE 4, 2025

Representatives from the American Association of Clinical Endocrinology (AACE), the Association of Program Directors in Endocrinology, Diabetes and Metabolism (APDEM) and the Endocrine Society joined for a portion of the meeting*. Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N.

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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Some members of the Specialty Board were interested in the LKA experience, participant survey results—particularly responses about fairness—and how LKA performance data might reflect on clinical outcomes. Community Practice in ABIM Governance* Erica N.

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ABIM

JUNE 24, 2025

Visit the ABIM Blog for reports of prior meetings. The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research.

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ABIM

MAY 30, 2025

Visit the ABIM Blog for reports of prior meetings. Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. Of note, the findings so far indicate that 90% of nephrologists who responded are clinically active.

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FDA Law

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. Since 1993, Congress has continued to direct the federal government, and in particular FDA, to take steps to close the gap in clinical research representation.

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FDA Law

MARCH 6, 2025

inpatient hospital, out-patient clinic), date range for the data, and location of the data collection sites (e.g., The DCP should follow applicable regulations governing human subject protections, where applicable. OUS data may introduce bias if the OUS population does not reflect the U.S. data acquisition device).

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The Clinical Problem Solvers

OCTOBER 11, 2021

In contrast, de jure segregation refers to the involvement of federal, state, and local governments in creating, structuring, designing, reinforcing, and perpetuating segregation. The Color of Law: A Forgotten History of How Our Government Segregated America. The Clinical Problem Solvers Podcast. Benjamins MR, De Maio F.

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FDA Law

AUGUST 3, 2022

And it came four years after the comprehensive federal legislation governing laboratories, again without mentioning FDA or referring to such tests as devices. Advocates of greater regulation point to the proliferation of clinically significant tests as evidence supporting the need for more oversight.

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FDA Law

NOVEMBER 18, 2021

PCR comparators for their clinical studies but refuses to publicly designate which ones are acceptable. We have had more than one client spend considerable time and money conducting a clinical study, only to be told that the comparator is not acceptable. That would significantly facilitate clinical study design.

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