Information, Manufacturing, Provider and Relationship

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

Manufacturing

Manufacturing Provider Medical IT

Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

FDA Law

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? In an appendix, FDA provides a model “decision check list” for patients. It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. What is going on here?

Manufacturing

Manufacturing Provider Patients IT

Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law

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

Referral

Referral Relationship Government Healthcare

CDRH Looks Towards the End of the Public Health Emergency and Transition for EUA and Devices Marketed Under Enforcement Discretion

FDA Law

MARCH 7, 2022

At a high level, FDA will be allowing manufacturers a period of no less than 180 days to submit a premarket submission for devices marketed under an EUA or an enforcement policy. Manufacturers planning to continue commercial distribution to submit a premarket submission (e.g., Copies of the guidances can be found here and here.

Manufacturing

Manufacturing IT Relationship Medical

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

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.

Clinic

Clinic Manufacturing Patients IT

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

FDA Law

OCTOBER 14, 2021

Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention or treatment of breast cancer have not been established. In this safety communication, FDA states: The U.S. 21 U.S.C. §

Patient-Centered

Patient-Centered Healthcare Manufacturing Provider

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

SEPTEMBER 20, 2021

requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners). Torrente, explained in a previous post , in-person meetings create important opportunities for building rapport, and lead to more robust dialogue and collegial relationships between the Agency and sponsors.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

JUNE 20, 2024

Widera and Smith have no relationships to disclose. Guests George Kuchel & Alison Huang have no relationships to disclose. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. That can be incredibly informative.

IT

IT Patient-Centered Patients Clinic

Ep. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D., of Roetzel & Andress

Physician's Practice

JUNE 9, 2025

a health care attorney and practice group manager with Roetzel & Andress, joins the show to break down the hidden legal risks of prescribing GLP-1 medications that physicians need to know about, from ensuring informed consent to navigating long-term safety data. Adler, J.D.,

Management

Management Telemedicine Patients Insurance

Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

MAY 5, 2022

COVID-19, masks, and hearing difficulty: Perspectives of healthcare providers. So this is a podcast going at the geriatricians and palliative care providers. And when you think about that, they’re hearing pieces of the information and their brain is trying to make sense of it. Alex: Great story. So they’re left out.

IT

IT Screening Hospital Clinic

Cannabis Advocates High On Recent Medical Marijuana Research Legislation

FDA Law

JANUARY 8, 2023

The report must also discuss the barriers associated with conducting research with cannabis and CBD in states that have legalized their use, how barriers might be overcome and whether public-private partnerships or federal-state partnerships can or should provide researchers with additional cannabis and CBD strains. Application Process.

Medical

Medical Manufacturing Electronics Provider

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? So when they do meet it, how are you going to be in relationship to it? Eric 24:59 Have to release any embargoed information with us. So I can say anything I want.

Illness

Illness IT Patient-Centered Patients

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

DECEMBER 7, 2023

What do we do to very concretely provide heat shelters and cool shelters? Ruth: And then to answer your question also about the different providers as far as nurses and physicians and respiratory therapists and pharmacists, most schools of medicine, nursing and all those other fields are including some climate change in their curriculum.

Healthcare

Healthcare IT Education Community

MedTech Conference Download

FDA Law

NOVEMBER 8, 2022

Below, we provide a snapshot of the three-day event: Update on the International Medical Device Regulators Forum (IMDRF). To paraphrase from our blog post , EUAs are triggered by an EUA declaration; FDA will publish advanced notice for an EUA declaration and provide a 180 day notice before the implementation of the transition plan.

Medical

Medical Manufacturing Patient-Centered Provider

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law

MAY 26, 2025

Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care. Department of Health & Human Services purporting to provide a comprehensive review of the evidence and best practices for promoting the health of children and adolescents with gender dysphoria.

Manufacturing

Manufacturing Provider Medical IT

Primary Care Digest

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

Trending Sources

Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

CDRH Looks Towards the End of the Public Health Emergency and Transition for EUA and Devices Marketed Under Enforcement Discretion

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

FDA Issues Unsupported Safety Warning Regarding Surgical Robots for Cancer Treatment

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

Urinary Incontinence Revisited: George Kuchel & Alison Huang

Ep. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D., of Roetzel & Andress

Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

Cannabis Advocates High On Recent Medical Marijuana Research Legislation

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

MedTech Conference Download

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

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