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The draft guidance provides recommendations for collection and reporting of chemical characterization data and discusses the topics of information gathering, test article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 ). By Adrienne R.

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The Clinical Problem Solvers

MARCH 14, 2025

Additionally, he consults with federal agencies on mental health system design and practices. Dr.  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.

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The Medical Futurist

MAY 18, 2025

They have started a large-scale clinical trial involving 10,000 patients, expected to last two years, with plans to obtain CE marking by the end of 2024. A human-sized, smiling robot combines the very best in cutting-edge technology and human touch to provide frequent check-ins and non-medical care for residents in long-term care settings.

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Today's Hospitalist

MAY 9, 2025

Since the mid-1990s, our capacity for innovation has never stopped as hospitalists navigate a complex landscape of acute illnesses, interprofessional collaborations and the imperative to provide efficient, high-quality care. It offers us a path toward reclaiming our time, reducing burnout and ultimately enhancing the care we provide.

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Priority Physicians

JANUARY 20, 2025

Priority Physicians Provides Care for Musculoskeletal Injuries But before you rush that sprained ankle to urgent care, consider this: At Priority Physicians, we have fellowship-trained sports medicine doctors with the proper credentials to handle musculoskeletal injuries knowledgeably.

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FDA Law Blog

NOVEMBER 10, 2024

In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2 The Agency announced the FY2024 funding for the three natural history study grant awardees provides $4.7 million over the next four years. million over four years.

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The Clinical Problem Solvers

APRIL 24, 2025

Additionally, he consults with federal agencies on mental health system design and practices. Dr.  The episode also explores how digital tools can help youth manage their mental health, while also noting the need for culturally relevant care providers. Accessed 2024. Ring the Alarm. The Crisis of Black Youth Suicide in America.

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FDA Law Blog

NOVEMBER 7, 2024

As an example, we filed a 513(g) request in December 2024. If a company and/or their regulatory consultant(s)/counsel have evaluated the product and determined it is not a device, the company can decide to proceed to market the product without contacting FDA. Sometimes, though, the question of classification defies an easy answer.

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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. KP Medical Device Consulting LLC By Adrienne R.

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FDA Law Blog

FEBRUARY 21, 2024

2, 2024, FDA’s Center for Veterinary Medicine (CVM) announced that it will withdraw its Program Policy and Procedures Manual Guide 1240.3605 (PPM). 1842 ) (Innovative FEED Act), introduced in 2023, would amend the FDC Act to provide CVM with the required authority. By Riëtte van Laack — On Feb. 6687 and S.

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PEMBlog

MAY 20, 2025

2024-066854. 2024-066855. We really do have so many resources at our disposal, and it is very hard for them to know everything about kids and adults while practicing in locations where they don’t have these consultants available 24/7. And so we routinely do outreach with our community providers. Pediatrics.

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FDA Law Blog

DECEMBER 7, 2023

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. DOJ has provided few bright lines about when conversations and disclosures to FDA may also satisfy its own VSD requirements.

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FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs December 5, 2024 draft guidance on accelerated approvals appears intended to cover each of these topics even if not by dividing them precisely along those lines.

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FDA Law Blog

AUGUST 12, 2024

Patent and Trademark Office consulted with FDA on the appropriate timelines, FDA claimed that the INAD, and thereby the testing phase, was not effective until August 4, 2011 because no NCIE was submitted until then. On August 8, 2024, the Court granted Nissan et al.’s When the U.S.

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PEMBlog

OCTOBER 18, 2024

Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. DMD patients often receive yearly MRIs to monitor their cardiac health, as discrepancies between MRI and echo findings are common.

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FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

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FDA Law Blog

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

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FDA Law Blog

JUNE 27, 2024

50,372 , 50,377 (June 13, 2024). Public Interest Factors The Controlled Substances Act provides that DEA may suspend or revoke a registration upon finding that the registrant has committed acts that would render the registration inconsistent with the public interest. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 21 U.S.C. §

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GeriPal

FEBRUARY 2, 2024

This week, we talk about the other major palliative care trial of default palliative care consults for hospitalized older adults with COPD, kidney disease, or dementia, published in the same issue of JAMA. and consulting for Papa Health. ABIM MOC credit will be offered to subscribers in November, 2024. laughter] Alex: Yeah.

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Physician's Weekly

JUNE 19, 2025

On a gloomy Friday in January, Johnson, a nurse practitioner who treats older adults, had a hospice consult with Ellen, a patient in her 90s in declining health. According to a 2024 survey , of the roughly 431,000 licensed nurse practitioners, 15% are, like Johnson, certified to treat older adults. “Hello. How are you feeling?”

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FDA Law Blog

JUNE 30, 2024

RAPS Convergence 2024 is set to host a must-attend session on CDRH’s Total Product Life Cycle Advisory Program (TAP), promising attendees an exclusive insight into a pioneering initiative aimed at improving the medical device commercialization landscape. Meet the Expert: Adrienne R. Lenz Adrienne R.

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PEMBlog

JUNE 2, 2025

Before your blood pressure rises as well, know that this PEMBlog article is here to provide an overview of the recognition and management of hypertensive emergencies. Hypertensive emergencies can result either from primary or secondary hypertension.

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ABIM

JUNE 4, 2025

In 2024, 77% of eligible ABIM Board Certified endocrinologists who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. They also noted a distinction in telehealth practices between remote consultations in different states and using telehealth to treat patients who live nearby.

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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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GeriPal

JUNE 5, 2025

JAGS 2024 Nursing Home Palliative Care Referral Process, Barriers, and Proposed Solutions: A Qualitative Study. And so we do have consultants who come in the building. And usually it’s simply for a consultation. So the palliative care service doesn’t necessarily need to provide those potentially.

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FDA Law Blog

MARCH 15, 2023

Current regulations do not require breast density notification to be part of the healthcare provider report or the lay summary to the patient. One key update to the regulation will require that facilities provide information to patients regarding the density of their breasts. The final rule will be effective on September 10, 2024.

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GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. ABIM MOC credit will be offered to subscribers in November, 2024.

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FDA Law Blog

MARCH 31, 2025

C) REMEDIES IN ADDITION.Remedies provided in this paragraph are in addition to, and not in lieu of, any other remedy provided by Federal law. 2117 (2024) (see our previous post here ), as well as a recent Executive Order ( EO 14215 ), titled Ensuring Accountability for All Agencies. Supreme Courts decision in SEC v.

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FDA Law Blog

APRIL 2, 2025

C) REMEDIES IN ADDITION.Remedies provided in this paragraph are in addition to, and not in lieu of, any other remedy provided by Federal law. 2117 (2024) (see our previous post here ), as well as a recent Executive Order ( EO 14215 ), titled Ensuring Accountability for All Agencies. Supreme Courts decision in SEC v.

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GeriPal

JANUARY 16, 2025

He died in 2024. But you worry that the advance directive does not provide enough guidance for the specific decision at Yael Jo, do you. So it defines unrepresented as someone who lacks decisional capacity to provide informed consent to a particular medical treatment. I’m a little bit of a throwback kind of 70s 80s guy.

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PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families. References Jeanmonod R, Asuka E, Jeanmonod D.

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FDA Law Blog

JUNE 14, 2023

He highlighted the following key features of TAP: An Innovative Approach To provide proactive support and guidance to medical device manufacturers, FDA has introduced a new CDRH position known as the “TAP Advisor.” up to 60 total products enrolled through FY 2024). up to 125 total products enrolled through FY 2025).

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GeriPal

JANUARY 11, 2024

A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. 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.

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GeriPal

APRIL 4, 2024

Bernie Lo discloses being an Honorarium Recipient and consultant for Takeda starting on 01/23/2024. 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.

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FDA Law Blog

JULY 9, 2024

The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate. DAP Goal Rationales The sponsor must also provide a rationale for the study’s proposed enrollment goals, including information and analysis to explain how these goals were determined.

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GeriPal

JANUARY 18, 2024

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. And Katie, as an advanced practice provider, is much better than I am at explaining how this works. Should they?

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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. I would consult a toxicologist because I know that this is rare. References Perry H, Burns MM. Ganetsky M (ed).

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