FDA Law Blog

MAY 29, 2025

As we recently blogged about here and here , FDA has issued guidance on lifecycle management for AI-enabled device software functions. Applying AI models to review large amounts of data from multiple manufacturers could help FDA identify early signals related to product quality and patient safety.

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Manufacturing Patient-Centered Medical Management 102

Vascular Physician

OCTOBER 26, 2021

What is Hyperbaric Oxygen Therapy and How it Helps Heal Wounds Hyperbaric oxygen (HBO) therapy involves treating patients with 100% oxygen (O2) at elevated atmospheric pressures in a specially designed chamber. Most patients lie on their backs or sit up just slightly.

Patient-Centered 52

Patient-Centered Diabetes Treatment Plan Insurance 52

Priority Physicians

JANUARY 27, 2025

Tips to Manage Anxiety If anxieties disable your daily life, discuss the situation with your direct primary care doctor. But in the meantime, we have a few tips that may help you manage anticipatory anxiety. Joseph Regional Medical Center in South Bend, IN and has a passion for putting his patients first in his practice.

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Primary Care Doctor Primary Care Board-Certified Physicals 52

FDA Law Blog

DECEMBER 4, 2023

Unusual Amounts and Dosages Dispensing high doses of opioids in quantities far exceeding the daily morphine milligram equivalent (“MME”) dose recommended by the Centers for Disease Control and Prevention (“CDC”). The Zarzamora decision identifies the following as prescribing red flags at issue in the case: 1. Complaint ¶ 57. (The

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Treatment Plan ER Government Patient-Centered 139

FDA Law Blog

JULY 10, 2024

Lenz, Principal Medical Device Regulation Expert — FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day workshop to help advance the use of patient-generated health data (PGHD) to support improved clinical trials, medical device development, and regulatory science.

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Patients Patient-Centered Clinic Medical 59

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. ACR also maintains a legislative action center for members to access advocacy updates. ACR operates an office in Washington, D.C.,

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

Physician's Practice

JUNE 20, 2025

Topics Access and Reimbursement Billing & Collections Coding & Documentation Finance Law & Malpractice MedMal by Coverys Patient Engagement & Communications Staffing & Salary Technology Media Video & Interviews Podcasts Medical World News Pearls Surveys Best States to Practice Great American Physician Survey Staff Salary Survey (..)

Management 52

Management Patient-Centered Appointment Patients 52

FDA Law Blog

FEBRUARY 19, 2023

Houck’s session will address pharmacists’ corresponding responsibility to identify and resolve controlled substance prescribing red flags and how to prepare for and manage DEA inspections. The session will occur Friday, March 24th. Pharmacists can earn 1 continuing practice education credit for attending this session.

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Patient-Centered Diabetes Education Community 59

PEMBlog

MAY 20, 2025

Learning Objectives Demonstrate the ability to use shared decision-making strategies when discussing imaging options with families of pediatric patients presenting to the Emergency Department. Optimizing Advanced Imaging of the Pediatric Patient in the Emergency Department: Policy Statement. Pediatrics. 2024;154(1):e2024066854.

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Families Family Hospital Patient-Centered 102

GeriPal

MARCH 14, 2024

This simple challenge was focused on putting ourselves in the shoes of our patients with dysphagia who are prescribed thickened liquids. Eric: Well, before we talk about dysphagia and revisit it, which is also interesting, because this is our first podcast, I think on dysphagia, but we’ve talked about it before on GeriPal, in our blog.

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IT Patient-Centered Hospital Individual 125

FDA Law Blog

AUGUST 28, 2023

The draft guidance Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (which we previously blogged on here ) includes information on selection, verification, validation, and usability of DHTs and was referenced frequently in responses to participant questions.

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Clinic Patient-Centered Medical IT 59

FDA Law Blog

APRIL 6, 2025

Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDAs Center for Drug Evaluation and Research (CDER), most recently as the Deputy Director, Division of General Endocrinology. We look forward to her development and future success here, said HPM Managing Director J.P. Ellison.

IT 59

IT Nurse Practitioner Patient-Centered Government 59

FDA Law Blog

OCTOBER 9, 2023

We previously blogged about this lawsuit last year. To help patients afford the copays and deductibles for specific medications, some drug manufacturers offer direct financial assistance, often as coupons, to subsidize the patient’s purchase of the drug at the point of sale.

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Insurance Manufacturing Patient-Centered Individual 40

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. The EKRA issue in this case centered on how Graves was compensated.

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Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

OCTOBER 10, 2023

Dr. Beitz served in leadership positions in FDA’s Center for Drug Evaluation and Research for nearly three decades. She completed her residency and a fellowship in medical oncology/hematology at Brown University, Roger Williams Medical Center, and Brown University Affiliated Hospitals.

Patient-Centered 49

Patient-Centered Relationship Clinic Management 49

FDA Law Blog

APRIL 23, 2023

Because an external control can involve the use of real-world data (“RWD”), the Draft Guidance notes that this guidance is being issued to satisfy, in part, requirements from the 21st Century Cures Act on the use of real-world evidence (“RWE”) in regulatory decision-making, similar to other recent efforts in this arena that we have blogged about.

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Patient-Centered Clinic Patients Provider 49

PEMBlog

OCTOBER 2, 2024

I’ll make the important distinction between gastritis – which is diagnosed only via endoscopy – and dyspepsia, the term best used to describe the symptoms many patients experience. The role of lifestyle and dietary modifications in management. Gastroesophageal Reflux: Management Guidance for the Pediatrician.

Diagnosis 52

Diagnosis Management IT Patient-Centered 52

FDA Law Blog

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

FEBRUARY 21, 2022

Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of New Drugs in the Center for Drug Evaluation and Research (“CDER”). From 1997 to 2003, Dr. Unger served as a medical officer, team leader, and subsequently branch chief in FDA’s Center for Biologics Evaluation and Research (“CBER”).

Patient-Centered 40

Patient-Centered Management Hospital Medical 40

FDA Law Blog

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. 220 and was described on HP&M’s blog here. The EKRA issue in this case centered on how Graves was compensated.

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law Blog

JUNE 22, 2022

It was alleged that other employees administered the medication to patients even after observing signs of tampering, although no patients were reported harmed. The NPA requires “management” review of “any discrepancies discovered during an employee’s blind count when accessing controlled substances.”

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law Blog

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

Patient-Centered 40

Patient-Centered Insurance Manufacturing Provider 40

FDA Law Blog

DECEMBER 11, 2023

Even assuming a 3% reduction in the 510(k) workload from the Third-Party Review Program, under FDA’s projections OHT7 will need to be staffed to review nine times the current capacity of the entire Center. [21] Fourth, the inability to manage this influx will harm the diagnostic industry, including manufacturers of distributed IVD products.

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IT Medical Patient-Centered Provider 69

FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC). By Holly N.

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Manufacturing Engineering Clinic Provider 59

Common Sense Family Doctor

FEBRUARY 1, 2025

Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians.

Hospital 52

Hospital Management Primary Care Primary Care Physician 52

Rao Doctor

APRIL 3, 2025

When assessing a fever, we doctors employ a systematic approach to ensure accurate diagnosis and effective management. Rectal method is more appropriate for infants, children and unconscious or comatose patients who are not able to hold the thermometer in their mouth. What are the Management and Treatment Options in a case of fever?

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Diagnosis Management Illness Diagnose 130

Aspiring Minority Doctor

DECEMBER 31, 2024

December 17 th marked 11 years since this blog has been in existence, but for the first time ever since its creation, I managed to go the entire year without a single post! If you've been reading my blog for a while, then you know I basically completed a General Surgery based intern year. I had definitely been missing out!

Medical Student 52

Medical Student IT Patient-Centered Medical 52

FDA Law Blog

MARCH 17, 2022

Houck — The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We We blogged on the final 2016 guideline here on March 17, 2016). By Larry K. Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed.

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Patient-Centered Clinical Practice Patients Individual 75

FDA Law Blog

JUNE 10, 2024

We also became aware that First Choice Surgical, an ambulatory surgical center in Cedar Rapids, Iowa, agreed to pay $125,000 to resolve allegations it failed to maintain complete and accurate records and failed to provide effective controls to guard against theft and diversion of controlled substances.

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Management Patient-Centered Hospital Healthcare 59

GeriPal

JANUARY 18, 2024

We start off the conversation by talking about whether patients with cancer and cancer pain are really that different, and their paper that was just published on January 11 th in JAMA Oncology showing that substance use disorder is not uncommon in individuals with cancer. Katie, welcome back to GeriPal. Jessie, welcome back to GeriPal.

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Illness Patient-Centered Screening Clinic 137

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 103

Illness Patient-Centered IT Patients 103

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.

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IT Patient-Centered Illness Education 127

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Learn More Subscribe to the ABIM Blog to stay on top of the latest news. The following is a summary of the spring meeting.

Board-Certified 52

Board-Certified Government Community Education 52

GeriPal

DECEMBER 8, 2022

Clinicians “catching” patient life stories. . Our patients aren’t “the 76 year old with heart failure in room 202,” as Heather Coats astutely noted. Storytelling Helps Hospital Staff Discover The Person Within The Patient. A few data based publication links from Person-Centered Narrative Intervention Program of Research: .

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Patient-Centered Illness Healthcare IT 116

The Clinical Problem Solvers

MAY 30, 2022

Kozhimannil—the Distinguished McKnight University Professor in the Division of Health Policy and Management at the University of Minnesota and Director of the Rural Health Research Center. Clinicians are able to shape the environment in which people give birth by caring for the earth and their patients.

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Community Patient-Centered Families Family 52

FDA Law Blog

NOVEMBER 29, 2022

CDC received some 5,500 comments from patients, caregivers, clinicians and interested organizations to the proposed guideline update it issued in February. We blogged on the 2016 guideline here in March 2016, and the proposed guideline here on March 18th). They do apply, however, to prescribing for pain management upon discharge.

Patients 52

Patients Patient-Centered ER Individual 52

GeriPal

DECEMBER 15, 2022

Along the way we address: Is this degree of slowed cognitive decline meaningful to patients or care partners? Eric: So patient narrative storytelling, independent of what we call it, I’d like to turn to both of you and just how you got interested in this as a subject. She was a heart failure patient.

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IT Patient-Centered Healthcare Illness 106