FDA Law Blog

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Just a day earlier, FDA’s Center for Devices and Radiological Health (CDRH) released a list of the guidance documents the Center intends to publish in the upcoming 2024 fiscal year.

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FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J.

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FDA Law Blog

NOVEMBER 20, 2024

The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article extraction, chemical analysis, and data reporting. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).

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FDA Law Blog

OCTOBER 6, 2023

However, meeting this timeline would require FDA to issue a final rule within approximately six months of the PR’s publication date—in other words, by April 2024. In addition, FDA proposes to continue to exercise enforcement discretion (i.e., As an example, the PR cites immunohistochemistry tests that involve no automation (e.g.,

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FDA Law Blog

AUGUST 18, 2024

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. The classification order identifies the special controls and therefore is extremely important.

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The Clinical Problem Solvers

MARCH 14, 2025

There are a growing number of Child Psychiatric Access Programs, including one in Massachusetts, which provide quick access to psychiatric consultation and facilitates referrals for accessing ongoing behavioral health care. Diversifying your mental health outreach goes hand in hand with diversifying your providers. Accessed 2024.

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FDA Law Blog

JANUARY 24, 2024

The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. As such, we can offer our readers a special 10% discount. Karst (Director, Hyman, Phelps & McNamara, P.C.)

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FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution. The discount code is: S10-826-826L24.S.

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FDA Law Blog

OCTOBER 2, 2024

As both these categories of changes are currently permitted via a PMA supplement, and the goal of FDORA is to provide an alternative to the need for such supplements, we would expect major changes and modifications to intended use to be permissible via a PCCP as long as the device remains safe and effective without any change.

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The Motivated MD

OCTOBER 10, 2024

So, with this chapter, I hope to briefly touch on the basics of market investing and describe why simple diversification and index fund investing are the most effective ways for busy clinical physicians and healthcare providers to invest with the expectation of long-term gains. Don’t try to beat the market; be the market.

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FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement.

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FDA Law Blog

MAY 7, 2025

The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th

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FDA Law Blog

DECEMBER 2, 2024

The ISO 10993-1: 2018 standard, in turn, describes contact duration as the cumulative sum of single, multiple, or repeated duration of contact, although we are aware that a draft version of the standard (ISO/DIS 10993-1:2024) may be heading in a similar direction to the draft guidance.

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PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. PMID: 30275251; PMCID: PMC6566852.

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PEMBlog

AUGUST 20, 2024

eCPR is typically performed in specialized centers with highly trained personnel in well coordinated teams. So we need to include pre hospital providers, the emergency medicine teams. This will provide the evidence needed for institutions to support the monumental financial and resource cost to set up eCPR programs in the first place.

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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). We do not address the technical and administrative details of the Discount Program here. Final Guidance at 2.

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Medical Xpress

JUNE 16, 2025

What is known is that special cells in the eye called intrinsically photosensitive retinal ganglion cells (ipRGCs) detect blue light and send signals to the SCN to reset the clock. The content is provided for information purposes only.

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Medical Xpress

JUNE 16, 2025

A 2024 study published in the journal Nature Medicine found that military veterans with brain injuries saw major mental and physical improvements after just one ibogaine session. The content is provided for information purposes only. Ibogaine is a psychedelic that causes powerful hallucinations and can last for hours.

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Physician's Weekly

JUNE 19, 2025

The number of nurse practitioners specializing in geriatrics has more than tripled since 2010, increasing the availability of care to the current population of seniors, a recent study in JAMA Network Open found. “We step into places where other providers may not, and geriatrics is a prime example of that.”

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ABIM

JUNE 4, 2025

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) In 2024, 77% of eligible ABIM Board Certified endocrinologists who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. or Canada to become eligible for ABIM Board Certification.

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The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. ’ Though it often does not come with the attending salary, medical trainees are getting paid to perform a service, and hospitals provide retirement plans to these individuals.

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FDA Law Blog

JUNE 10, 2024

The hospital also “entered into a Memorandum of Agreement with the DEA requiring Palomar Health to undertake additional measures to increase security, implement specialized training, and to handle controlled substances properly and safely.” DEA, Palomar Hospital Pays $250,000 for Diverting Fentanyl ( June 3, 2024 ).

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ABIM

MAY 30, 2025

In 2024, 77% of ABIM Board Certified nephrologists due for an assessment opted for the LKA over the traditional, 10-year MOC exam. Dr. Adey has provided updates to the Nephrology Board about this process at the last two meetings ( fall 2024 and spring 2024 ). Additionally, participation in LKA remains a leading choice.

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GeriPal

JANUARY 25, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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ABIM

JUNE 11, 2025

In 2024, 75% of infectious disease physicians who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. Several members of the Infectious Disease Board noted that allowing applicants to select multiple categories and provide written details helps reflect the diversity of practice in the field.

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GeriPal

JUNE 5, 2025

Despite these substantial needs, specialized palliative care beyond hospice is rare in nursing homes. How to think about primary and specialized palliative care in this setting. JAGS 2024 Nursing Home Palliative Care Referral Process, Barriers, and Proposed Solutions: A Qualitative Study. Eric 13:49 Right.

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FDA Law Blog

APRIL 8, 2024

MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017.

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PEMBlog

JANUARY 16, 2025

Learn how to recognize and manage cases in the emergency department, ask the right questions to uncover inhalant use, and provide critical resources for prevention and support. Updated February 26, 2024. Further complicating matters is that each inhalant has its own special risks. References Perry H, Burns MM. Ganetsky M (ed).

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GeriPal

JULY 11, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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PEMBlog

MARCH 27, 2024

My special guest podcaster, Emily Groopman, is an actual Pediatric Geneticist in training and we hope that you will find this episode useful. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. So my special guest host on this episode is a trainee in pediatrics and medical genetics. Inborn Errors of Metabolism. Pediatr Rev.

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GeriPal

APRIL 4, 2024

Arguing for the state of Missouri against the Cruzan’s was Ken Starr, who would later be assigned the role of special prosecutor in the investigation of the Clintons (Whitewater, Lewensky, etc). Bernie Lo discloses being an Honorarium Recipient and consultant for Takeda starting on 01/23/2024.

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GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Alex: Okay.

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New South Family Medicine and MedSpa

NOVEMBER 24, 2022

Direct primary care offers you and your family top-notch health care, and so much more.like a high patient and provider satisfaction with an improved quality of care. Providers at New South Family Medicine and MedSpa can address the patient's deeper needs, rather than trying to rush through a hectic day full of too-brief appointments.

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GeriPal

MAY 9, 2024

Why focus on the public rather than other health care providers? It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. ABIM MOC credit will be offered to subscribers in November, 2024. AMA PRA Category 1 credit(s) ™. Julie: I have one.

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GeriPal

FEBRUARY 8, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

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GeriPal

JUNE 13, 2024

I feel like I recognize it when I see it, but I struggle to give a clear definition or provide effective ways to address it. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. AMA PRA Category 1 credit(s) ™. Alex 03:31 That was fun.

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GeriPal

APRIL 6, 2023

To provide context, we are joined by Karen Steinhauser, a social scientist at Duke who has been studying spirituality for years (and published one of the most cited papers in palliative care on factors considered important at the end of life , as well as one of my favorite qualitative papers to give to research trainees ).

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