FDA Law

OCTOBER 2, 2023

However, the two previous FDA guidance documents, released in May 1998 ( Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products , available here ) and December 2019 ( Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products , available here ), differ from the new guidance.

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FDA Law

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ). Valentine & Larry J.

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FDA Law

AUGUST 9, 2021

Farquhar — On the heels of Genus Medical Technologies’ successful lawsuit against FDA—Genus was represented by Hyman, Phelps & McNamara PC—in both the District Court of D.C. The Federal Register Notice specifically addresses medical imaging products, like those at issue in the Genus case. Koblitz & Douglas B.

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IT Medical Complication Provider 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Our guests explain how we can incorporate race-conscious medicine in clinical settings, medical education, and biomedical/epidemiological research to responsibly recognize and address the harms of racial inequality. Nwamaka Eneanya and Jennifer Tsai to discuss the limitations and harms of race-based medicine in clinical practice.

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BMJ

JULY 17, 2020

A multilayered view of stigmatizing discourses lays the foundation for eliciting a series of suggestions for quelling stigma, to be implemented at the individual, community, and national levels, as suggested by the WHO. Psychological health during the coronavirus disease 2019 pandemic outbreak. Scholars such as Wen et al.

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Aspiring Minority Doctor

APRIL 17, 2021

For the 2019 cycle, I spent a total of $372, and the total spent on the 2020 cycle was $353 (and I forgot to register for SOAP, so did not participate this year). For the 2019 cycle, I spent a total of $372, and the total spent on the 2020 cycle was $353 (and I forgot to register for SOAP, so did not participate this year).

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FDA Law

OCTOBER 11, 2022

Additional guidance on confirmatory evidence is sorely needed as the December 2019 draft guidance spends just two of its 18 pages telling us what FDA thinks of such a key piece of statutory language. Sasinowski & James E.

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FDA Law

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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FDA Law

NOVEMBER 6, 2022

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. Background.

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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. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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Clinic Medical Provider Patients 52

FDA Law

MAY 8, 2023

Baumhardt, Senior Medical Device Regulation Expert & Philip Won & Gail H. In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications. See 21 CFR 807.81(a)(3)

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FDA Law

JUNE 28, 2021

Under current Minnesota law enacted in May 2019, manufacturers that sell, deliver, or distribute into or within Minnesota 2 million or more units of an opiate are required to pay an annual product registration fee of $250,000.

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FDA Law

OCTOBER 14, 2024

The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” 588, 566 (2019)). Defendants may also seek en banc review of the decision from the full Ninth Circuit. Robbins , 519 U.S.

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FDA Law

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

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FDA Law

JUNE 29, 2022

For CDER specifically, the division must discuss the proposed rescission with CDER’s Medical Policy Council prior to notifying the sponsor. The Medical Policy Council’s role, as described in the MAPP, is to discuss decisions to rescind to ensure consistency in policy implementation across review divisions.

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GeriPal

NOVEMBER 9, 2023

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. Summary Transcript Summary Coaching is in. When I was a junior faculty, coaching wasn’t a thing. We address: What is coaching? How does it differ from therapy? link] Transcript Eric: Welcome to the GeriPal podcast. Indeed, matey.

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FDA Law

JANUARY 31, 2022

The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. attorneys’ offices since 2019, the Complaint seeks monetary and permanent injunctive relief ( see 21 U.S.C. §§ 832(f)(1) and 882(a)).

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FDA Law

JULY 10, 2023

Lenz, Principal Medical Device Regulation Expert — It takes a significant amount of time, cost, and effort to prepare a premarket notification 510(k) submission. In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. By Philip Won & Adrienne R.

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FDA Law

JANUARY 6, 2022

Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.” 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

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FDA Law

JUNE 23, 2021

As someone who studied in the fields of public health, medical sociology, and biomedical ethics, I was impressed with how quickly the pharmaceutical and biotechnology arena caught up with what took many decades to occur in the context of the physician-patient relationship. It harkens to the paternalism in medicine of the past.

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FDA Law

FEBRUARY 27, 2024

Consequently, because both applications were approved at the same time, both applications represent the first permitted commercial marketing or use of the product or the individual active ingredients, as outlined under 35 U.S.C. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”). l 56(c)(4) and 37 C.F.R.

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GeriPal

MAY 18, 2023

Summary Transcript Summary Hot off the press is a brand spanking new updated 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. The Beers Criteria is one of the most frequently cited reference tools in geriatrics, detailing potentially inappropriate medications to prescribe to older people.

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Medical IT Patients Clinic 97

The Clinical Problem Solvers

APRIL 5, 2022

Do you have a medical respite center? Push back against individual narratives that blame individuals for systemic injustice. Calac, Victor A. Lopez-Carmen, MPH, Naomi F. Our guests remind us to ask our patients about their housing status using non-judgmental and non-stigmatizing language. Know your community resources.

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BMJ

FEBRUARY 8, 2021

7 The same degree of focus has not been paid to misuse of other prescription medications which also have high abuse potential among youth, including medications such as prescription stimulants, tranquilizers, and sedatives. misuse of prescription medications). 2 Opioids contribute a large share of this overdose crisis.

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The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

Community 52

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GeriPal

MARCH 2, 2023

AFP 2019 Gabapentin for chronic neuropathic pain in adults. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. Cochrane Database of Systematic Reviews Review.

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GeriPal

MARCH 24, 2023

We also have Joe Shega, who is a hospice physician, and he is a Chief Medical Officer and Vice President at VITAS Healthcare. For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. I’m excited.

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The Clinical Problem Solvers

OCTOBER 11, 2021

individual bias or bigotry that leads to a failure to sell a home to a person of color) and personal choices ( e.g. Black people prefer to live among other Black people) is referred to as de facto segregation. These gaps are not a product of lifestyle choices, biology or individual behaviors. Episode Takeaways: 1. doi:10.1001/jama.2020.9289

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The Clinical Problem Solvers

DECEMBER 20, 2021

Fields Guests: Thu Quach, PhD, and Tung Nguyen, MD Time Stamps 00:00 Introduction 04:00 How Dr. Thu Quach’s and Dr. Tung Nguyen’s journeys shape their work 11:40 Policy work as a way of mitigating burnout 12:55 Balancing individual and communal focus (include?) provision in only English +/- Spanish), limitations of medical technology (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

GeriPal

MARCH 9, 2023

In our prior podcast with Ira Byock on psychedelics in 2019 we talked primarily about the potential of psychedelics. Brian: For the use of substances like psilocybin and LSD in medical care, or at least in investigational treatments, I like to call it psychedelic therapy. Eric, did you take your ketamine before this podcast?

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GeriPal

NOVEMBER 2, 2023

Alex: Today we’re delighted to welcome Jerry Gurwitz, who is a geriatrician and professor of medicine at the UMass Chan Medical School. I’ve seen this question come up a lot since finishing fellowship nearly two decades ago. Eric: And Alex, who do we have with us today? Jerry, welcome to GeriPal. Jerry: Great to be here.

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GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. It’s there.

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Illness IT Patient-Centered Patients 107

FDA Law

FEBRUARY 9, 2022

DEA regulations state that a pharmacist has a corresponding responsibility not to fill a prescription unless it is issued for a “legitimate medical purpose by an individual practitioner acting in the usual course of [their] professional practice.” Holiday CVS, 77 Fed. at 62,341; see Jones Total Healthcare Pharmacy, L.L.C. 27, 2010).

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GeriPal

APRIL 13, 2023

Summary Transcript Summary Social connections impact our health in profound ways, whether it is the support we receive from family and friends in navigating serious illness, the joy from shared social activities, or connecting with our community. Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. Alex: Great.

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GeriPal

FEBRUARY 27, 2025

Alex 00:27 And we’re delighted to welcome S a ch Kale, who is a palliative care doc at the Ohio State University Wexner Medical Center. But my medical training kicked in. Do you need to be an addiction medicine trained physician to start such a clinic (no: Sach is not). See Sachs write up about setting up this clinic in JPSM.

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Patients Clinic Patient-Centered Illness 72

Medical Xpress

JUNE 8, 2025

Sucrose is thought to activate centers of the brain that modulate pain and lead to the release of endorphins , but the exact mechanism remains unclear. It has become the worldwide standard of care for acute neonatal pain, but it doesnt seem to be helping in the long term. Read the original article.

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FDA Law

APRIL 18, 2022

In its communication released with the GFI, FDA stated that it received many comments on its previous 2019 draft guidance. In its communication released with the GFI, FDA stated that it received many comments on its previous 2019 draft guidance. The circumstances under which FDA does not intend to take enforcement action (i.e.,

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