FDA Law Blog

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). FDA may request additional information during the review of the PCCP.

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Vascular Physician

FEBRUARY 23, 2020

Vascular Institute of the Rockies 5-7 years of training after medical school specializing in learning about all aspects of peripheral vascular disease. Because vascular surgeons have the skills to provide every treatment of vascular disease, they can help individualize the treatment of each patient to what will work best for them.

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East Cary Family Physicians

JANUARY 30, 2024

As we embark on Glaucoma Awareness Month, East Cary Family Physicians is unwavering in our commitment to highlight the pivotal role of vision health, with a special emphasis on the early detection of glaucoma. Early detection not only facilitates effective management but also significantly reduces the risk of vision loss.

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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. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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FDA Law Blog

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device.

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Vascular Physician

DECEMBER 11, 2023

Diagnosis and Treatment of AVFs AVFs are diagnosed by a healthcare provider. If the healthcare provider suspects you have an AVF, they will request other tests to confirm it. If the healthcare provider suspects you have an AVF, they will request other tests to confirm it.

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FDA Law Blog

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 21 U.S.C. § 21 U.S.C. §

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FDA Law Blog

MARCH 9, 2025

The conference is the premier event on cosmetics and personal care products, where industry leaders will provide essential updates on compliance with Modernization of Cosmetics Regulation Act of 2022 (MoCRA), state legislative reforms, and new FTC advertising guidelines. FDA Law Blog is a conference media partner.

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FDA Law Blog

MARCH 3, 2025

From funding innovations and AI in drug discovery to navigating legal and compliance challenges, this conference will provide you with the opportunity to gain the insights you need to drive scientific advancements to global market success. FDA Law Blog is a conference media partner. Hyman, Phelps & McNamara, P.C.s

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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

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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FDA Law Blog

JULY 26, 2021

The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law. cGMPs, adverse events monitoring, risk management and recalls. FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount.

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FDA Law Blog

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 21 U.S.C. § 21 U.S.C. §

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Vascular Physician

FEBRUARY 14, 2024

Types of Compression Therapy The two key types of compression therapy include graduated compression stockings and compression bandages: Graduated Compression Stockings These special stockings fit tighter than regular sock. Alternatives to compression therapy include leg elevation, exercise, weight management, and medications.

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FDA Law Blog

OCTOBER 31, 2022

We have followed it over the last five years, with blog posts here , here , here , here , here , here , and here. It was noted that authorizing a device through a De Novo would create pilot specific special controls that other companies would need to follow, even if not participating in the pilot program. Key Findings at 12.

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FDA Law Blog

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. FDA Law Blog is a conference media partner for this event. The discount code is: S10-826-826L24.S.

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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. She also specializes in medical device software and digital health. Ellison, Managing Director at HPM.

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Manufacturing Management Utilities Relationship 59

FDA Law Blog

MAY 20, 2021

Houck — Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K.

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FDA Law Blog

MAY 20, 2021

Although we blogged on Drug Enforcement Administration (“DEA”) cyclic and on-site inspections in June 2014, we thought it helpful to update registrants on what they can expect as diversion investigators resume activities following the Covid-19 shutdown. By Larry K.

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FDA Law Blog

DECEMBER 2, 2024

We noted that the draft guidance’s discussion on determining a device’s contact duration raised concern as it contradicted ISO 10993-1:2018, Biological evaluation of medical devices —Part 1: Evaluation and testing within a risk management process. By Adrienne R.

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FDA Law Blog

APRIL 6, 2025

For nearly two decades, Dr. Lowy provided leadership across a range of important therapeutic areas, including general endocrinology, pain/opioids, cardiology, neurology, and psychiatry. Before her legal career, Julie worked as a nurse practitioner specializing in neurosurgery and infectious diseases. Ellison.

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IT Nurse Practitioner Patient-Centered Government 59

FDA Law Blog

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

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FDA Law Blog

MAY 4, 2023

In a DCT, trial-related activities may occur in trial participants’ homes, at local health care providers’ offices, or in local clinical laboratories. This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ).

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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. Focus on making the product great, and the profits will follow.

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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.

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Finance Insurance Individual IT 52

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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FDA Law Blog

SEPTEMBER 26, 2022

provides an optional alternative streamlined approach for current good manufacturing practices (cGMPs) for manufacturers of drug-device combination products (CPs). FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. 21 C.F.R. § or that FDA proposes can satisfy the requirements in § 4.4

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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.

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FDA Law Blog

FEBRUARY 22, 2023

And HF‑related AI requests are especially nerve‑racking to manage, because of the ever‑present threat that the study must be repeated to adequately respond. as a de novo special control or in a guidance document for a specific device type). Industry would certainly welcome guidance intended to smooth the HF aspects of 510(k) reviews.

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Mesa Family Physician

JUNE 11, 2025

In this blog, we’ll break down what preventive care involves, explore its relationship with short-term health insurance, and explain why it’s a critical part of staying healthy at any stage of life. Primary Care and Preventive Care: How They Work Together Primary care providers are often your main point of contact in the healthcare system.

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ABIM

JUNE 4, 2025

Visit the ABIM Blog for reports of prior meetings. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) The following is a summary of the spring meeting. or Canada to become eligible for ABIM Board Certification.

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FDA Law Blog

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). User Interface Software Description Section VI.B

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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.” Palomar Health self-disclosed to DEA that one of its employees may have diverted the fentanyl.

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FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance.

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ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. 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. Learn More Subscribe to the ABIM Blog to stay on top of the latest news.

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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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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. We got some really special guests with us. And how am I going to manage their pain? Article on buprenorphine in the elderly.

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Illness Patient-Centered IT Patients 103