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The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ).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 provides definitions for the three datasets.

Manufacturing 71

Manufacturing Management Specialization Provider 71

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. However, I so commonly see individuals inflate their lifestyle by overextending themselves when buying a home.

Finance 52

Finance Insurance Individual IT 52

FDA Law Blog

MARCH 2, 2022

The revised immediately effective guidance states that products categorized as “household substances” and only intended for institutional use must be sold in special packaging under the PPPA guideline. Yet, as CPSC acknowledges, the PPPA requires certain household substances to be packaged in accordance with special packaging standards.

Specialization 52

Specialization Individual IT Provider 52

FDA Law Blog

JULY 10, 2023

In this blog post, we will first briefly outline the procedural steps in the 510(k) review process for medical devices. Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. By Day 90 FDA sends final MDUFA Decision on 510(k).

Provider 75

Provider IT Engineering Medical 75

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 This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ).

Clinic 59

Clinic Telehealth Provider Electronics 59

FDA Law Blog

JULY 12, 2022

As discussed in our prior post on the CCP ( here ), the CCP is currently a submission tracker providing details of completed and upcoming dates. On June 30, individuals with access to the CCP (i.e., The pilot will be available to applicants planning to submit Traditional, Special, or Abbreviated 510(k)s.

Electronics 52

Electronics Individual Specialization Physicals 52

FDA Law Blog

MAY 8, 2023

FDA recommends that PCCPs specify only a “limited number” of modifications but does not provide a limit on the number of modifications that can be included. If the proposed performance evaluation methods are different from the original methods used, the manufacturer should describe the differences and provide a justification for the changes.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law Blog

MARCH 16, 2023

This device is indicated for the following use: for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., In the best tradition of teasers, keep reading our blog.

Healthcare Professional 40

Healthcare Professional Specialization Transportation Diagnosis 40

FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee. 151.066, Subd.

Hospital 52

Hospital Manufacturing Specialization Medical 52

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

Referral 59

Referral Relationship Government Healthcare 59

FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature).

Patients 52

Patients Patient-Centered Clinic IT 52

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. The investigators select the drugs they will audit.

Management 40

Management Consulting Provider Physicals 40

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. The investigators select the drugs they will audit.

Management 40

Management Consulting Provider Physicals 40

Aspiring Minority Doctor

FEBRUARY 7, 2023

It made me feel so special and loved. Food is extremely expensive in Bora Bora, so I am so grateful for the room credit that this retreat provided, because just getting a burger, salad, and dessert was over $100. Even cooler, the photographer took individual headshots of us that will be able to use for branding or however we like.

IT 52

IT Medical Mental Health Patients 52

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.

Board-Certified 52

Board-Certified Government Community Education 52

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

However, people need to understand what works best for them individually. Eating fruit provides excellent health benefits and is part of a healthy plate. Fruits provide nutrients vital for health and maintenance of your body. Fiber containing foods such as fruits help provide a feeling of fullness with fewer calories.

Referral 40

Referral DO Family Medicine Primary Care 40

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.

IT 126

IT Patient-Centered Illness Education 126

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. So my special guest host on this episode is a trainee in pediatrics and medical genetics. In other words, which features of the disease individuals with the mutation show for these conditions.

Consulting 59

Consulting Individual Family Families 59

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . We got some really special guests with us. 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. Transcript. This is Eric Widera.

Illness 102

Illness Patient-Centered IT Patients 102

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.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

MARCH 30, 2023

This week we’ve invited three guests to share their stories about storytelling that’s written for healthcare providers. I started blogging as a patient, just talking about my own story online like patients did back in the day. I was like maybe I’ll write a blog post about this later. It feels special to me.

IT 96

IT Patient-Centered Patients Healthcare 96

GeriPal

SEPTEMBER 22, 2022

One bump is just the classic pitfalls we often talk about in serious illness communication: being very jargony, very information focused, and just providing information. All these studies in this fringe… We want the special key. And oftentimes the existential landscape of serious illness, there’s no special thing.

Illness 101

Illness IT Patient-Centered Patients 101

GeriPal

MARCH 16, 2023

We have two authors, books, op-eds, prolific authors, and today’s podcast is a two-part special. So this week we’re going to be talking about writing for the lay public, and next week we’ll be publishing a podcast on writing for healthcare providers. When I write, I learn a ton from that.

IT 105

IT Healthcare Professional Healthcare Transportation 105

FDA Law Blog

MAY 13, 2025

Weve blogged about Most-Favored-Nation (MFN) drug pricing and how the new EO goes well beyond the 2020 order and questions we have. Given that the provision in the May 12 EO may be a rehash of what occurred in 2020, we thought it would be helpful to provide a bit of history and background on personal importations. 384(j)(2).

Manufacturing 59

Manufacturing IT Individual Provider 59

FDA Law Blog

NOVEMBER 8, 2023

Koblitz & Philip Won — The first anniversary is always special. The rule also aimed to provide “consumers with perceived mild to moderate hearing loss with improved access to devices that meet their needs and are less expensive than current options.” By Jeffrey N. Gibbs & Sara W. Access has expanded.

Utilities 64

Utilities IT Engineering Appointment 64