FDA Law Blog

MAY 27, 2024

Jennifer’s combination of experiences as in-house counsel for both large and start-up companies as well as outside counsel provides clients invaluable expertise and problem-solving skills. Ellison, Managing Director at HPM. Having worked with Jennifer for six years previously, I am truly excited to have her return.

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Manufacturing Management Utilities Relationship 59

FDA Law Blog

DECEMBER 16, 2024

We previously discussed the Third Party Review Program in a blog post last year when FDA mentioned its expansion as part of its plan to address the resource gap for review of laboratory developed tests (LDTs) under the LDT final rule. FDA), and to generate data in a format that would streamline FDAs review.

Consulting 52

Consulting Manufacturing Utilities Provider 52

FDA Law Blog

APRIL 30, 2024

This hardly provides clarification and seems to limit the topics that could utilize this method of feedback. However, Table 1 states that if the SIR request is received within 60 days of the FDA “marketing submission letter” FDA would, resources permitting, have the meeting or provide written feedback within 21 days.

Utilities 64

Utilities Provider Medical IT 64

PEMBlog

AUGUST 30, 2023

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

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Asthma Electronics Utilities Clinical Practice 52

Physician's Practice

JUNE 25, 2025

Reynolds Blog Video Neil Baum, MD, asks whether your patients are satisfied with their care and shows how a quick survey could make the difference. He has written ten books on practice management and the business of medicine. June 25, 2025 By Neil Baum, MD Fact checked by Keith A. He has written a book, What’s Going on Down There?

Patients 52

Patients Private Practice Management Healthcare 52

Physician's Practice

JUNE 27, 2025

Reynolds Blog Article The small details, like restroom cleanliness, shape patient perceptions and impact healthcare experiences in practices. All the staff agreed that it was not a representation of the care we provide our patients.

Management 52

Management Private Practice Patients Medical 52

PEMBlog

SEPTEMBER 27, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not. for bronchiolitis and 1.5%

Patients 52

Patients Illness Hospital Management 52

The Motivated MD

DECEMBER 18, 2024

I am using our weekly blog posts to create a future book that hopefully will apply to medical trainees and early career physicians looking to build generational wealth, get out of debt, and take control of their financial lives. I am in no way, shape, or form a financial professional, nor does this site provide formalized financial advice.

Finance 52

Finance Insurance Individual IT 52

Physician's Practice

JUNE 20, 2025

Reynolds Blog Article Innovative medical practices thrive by embracing change, prioritizing patient care and learning from setbacks to enhance success and satisfaction. This blog will discuss what early adopters do to implement innovative and exciting practices.

Management 52

Management Patient-Centered Appointment Patients 52

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law Blog

JUNE 3, 2021

The state is supposed to provide manufacturers with written notice of noncompliance and administrative penalties may not be assessed if the manufacturer submits the required report or fee within 45 days after receiving the notice of noncompliance. North Dakota. The North Dakota law includes three reporting requirements for drug manufacturers.

Manufacturing 52

Manufacturing Supply Chain Insurance Provider 52

FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. 14] Thus, while the Third-Party Review Program is not well‑utilized generally, it is not utilized at all by the in vitro diagnostic industry.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

APRIL 23, 2023

The analytic method should identify and manage sources of confounding and bias, including a strategy to account for differences in baseline factors and confounding variables, and missing and misclassified data. This Draft Guidance focuses on the use of patient-level data from other clinical trials or from RWD sources.

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Patient-Centered Clinic Patients Provider 49

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. Some of these will be subjects of more detailed posts in the future and readers should keep an eye on the blog for additional coverage.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

MARCH 20, 2022

To clarify what preparations companies should take to more seamlessly manage a recall, on March 2, 2022, FDA published its Final Guidance Document on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. The Guidance provides practical guidelines for both firms and direct accounts. Product coding (e.g.,

Electronics 40

Electronics Manufacturing Provider IT 40

PEMBlog

SEPTEMBER 13, 2023

This is a blog post designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

Patients 52

Patients Screening Illness Physicals 52

FDA Law Blog

OCTOBER 28, 2021

the plan or issuer must defer to the determination of the prescriber) and that for any reasonable medical management techniques utilized within a specified method of contraception, “plans and issuers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or provider.”

Insurance 40

Insurance Utilities Individual Provider 40

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . Management of chronic pain in the elderly: focus on transdermal buprenorphine. So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen.

Illness 102

Illness Patient-Centered IT Patients 102

FDA Law Blog

FEBRUARY 22, 2022

The NIH also only accepts manufacturers into the program if they can demonstrate the ability to provide high volumes (e.g., For those accepted, the NIH provides a comprehensive team of project management and scientific experts to help the manufacturer prepare a viable EUA application. What should be done?

Manufacturing 52

Manufacturing Screening Provider Clinic 52

FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. pricing, among other things.

Manufacturing 59

Manufacturing Utilities Provider IT 59

PEMBlog

MARCH 27, 2024

This episode will help you better prepare for and manage children with inborn errors of metabolism in the Emergency Department. She did her MD/PhD at Columbia University, where she investigated the diagnostic utility of exome sequencing for kidney disease. You can contact her via email at egroopman@childrensnational.org.

Consulting 59

Consulting Individual Families Family 59

GeriPal

DECEMBER 19, 2024

We invited Dani Chammas , a palliative care physician and psychiatrist at UCSF (and a frequent guest to the GeriPal podcast), as well as Brent Kious , a psychiatrist at the Huntsman Mental Health Institute, focusing on the management of severe persistent mental illnesses. So it’s a lot of palliation. I gotta get some sleep.

Illness 101

Illness Mental Health IT Patient-Centered 101

FDA Law Blog

NOVEMBER 16, 2021

First, section 90006 imposes a moratorium on HHS’s implementation of an HHS OIG final rule, published on November 30, 2020, which amends the Federal health care program antikickback statute safe harbors as they apply to drug rebates paid to Medicare Part D plans and Medicaid Managed Care plans (or their PBMs).

Manufacturing 40

Manufacturing Utilities Management Provider 40

PEMBlog

APRIL 26, 2023

Studies demonstrate that utilizing one of these storage methods can reduce the suicide and unintentional gun deaths in children by up to 54%. [ Kristen ] Great question. In our current environment, it can feel overwhelming as a healthcare provider to discuss firearms. You can purchase these for about $25-100.

Family 52

Family Families Mental Health Healthcare 52

GeriPal

SEPTEMBER 19, 2024

So, basically, with a stepped care model, the goal is to tailor care delivery to the patient’s needs while at the same time utilizing less clinician resources. So at our cancer center, we have physicians, advanced practice providers. Or the article that, the fast food article, to use the parlance from the blog post.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

FDA Law Blog

OCTOBER 29, 2023

Since that blog post, an important step forward was the decoupling of the coverage requirement from the FDA Birth Control Guide in the guidance provided by the Department to plans and issuers.

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Individual Insurance Healthcare Provider 45

FDA Law Blog

SEPTEMBER 14, 2021

A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. The AIM price is the volume-weighted average price of the drug in Australia, Canada, France, Germany, Japan, and the U.K. PART 2: INFLATION REBATES UNDER MEDICARE PARTS B AND D.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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Manufacturing Supply Chain Patient-Centered Utilities 98