FDA Law Blog

MARCH 7, 2024

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. Both documents also note that FDA may request copies of the DMC meeting records when the study is completed, and access to the electronic data sets used for each set of interim analysis.

Clinic 105

Clinic Provider IT Utilities 105

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. If your patients are unhappy with care then they probably won't come back to your practice. June 25, 2025 By Neil Baum, MD Fact checked by Keith A.

Patients 52

Patients Private Practice Management Healthcare 52

FDA Law Blog

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. Providers should be aware of the other drugs prescribed to their patients. By Larry K. Complaint ¶ 58.

Treatment Plan 139

Treatment Plan ER Government Patient-Centered 139

FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time.

Electronics 59

Electronics Manufacturing Provider Medical 59

FDA Law Blog

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. Rather than looking at how RWD/RWE provide meaningful information on safety and effectiveness, reviewers often focus on perceived gaps.

Medical 111

Medical Clinic Patients IT 111

FDA Law Blog

SEPTEMBER 22, 2024

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. By Steven J. Gonzalez & Lisa M. There is no cost associated with obtaining an FEI Number.

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law Blog

FEBRUARY 27, 2025

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

Clinical Practice 88

Clinical Practice Clinic Government Management 88

FDA Law Blog

SEPTEMBER 11, 2023

This announcement addresses one of the commitments in FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. Over the years, we’ve blogged on similar initiatives related to the 510(k) pathway. In a statement released at the time, CDRH Director Jeffrey Shuren, M.D.,

Medical 64

Medical Electronics Manufacturing Utilities 64

FDA Law Blog

NOVEMBER 20, 2024

Chemical characterization identifies and quantifies chemicals that may be released from the medical device, while a toxicological risk analysis (TRA) evaluates the risks to the patient associated with the chemicals identified. Data from chemical characterization studies must be evaluated in a separate TRA following ISO 10993-17 guidelines.

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

JUNE 21, 2023

According to the announcement, enabling patients to access medical devices beyond traditional clinical settings can help close the healthcare gap by delivering care “directly to patients, wherever they are – at home, at work, in cities, in rural communities.” and remote or wearable patient monitoring devices (e.g.,

Medical 45

Medical Patients Healthcare Electronics 45

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.

Asthma 52

Asthma Electronics Utilities Clinical Practice 52

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.

Finance 52

Finance Individual Management IT 52

FDA Law Blog

AUGUST 27, 2023

The compliance policies described in the Guidance focus on the requirement that, beginning November 27, 2023, all trading partners generally will be required to use electronic-based approaches to meet the enhanced drug distribution security requirements set forth in in FDCA section 582(g)(1) (Enhanced Drug Distribution Security).

Supply Chain 52

Supply Chain Electronics Manufacturing Provider 52

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

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. By John W.M. Combination products might be part drug, part device, or part software or hardware.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

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. Neil Baum, MD Successful practices do not follow others; rather, they make their own paths and follow their own pathways and agendas.

Management 52

Management Patient-Centered Appointment Patients 52

FDA Law Blog

OCTOBER 24, 2022

These data are routinely collected from a variety of sources, such as electronic health records, providing information on health and healthcare in actual patients, rather than in the controlled environment of a clinical trial. This value is potentially even greater for rare diseases, where there are limited sources of data.

Electronics 78

Electronics IT Healthcare Patients 78

FDA Law Blog

DECEMBER 6, 2024

This summary covers everything from format and contents of INDs to their submission and use of the Electronic Submissions Gateway to cross-referencing other applications to FDAs review of the IND and the associated timelines. For cell therapy products, the draft guidance notes that in vivo imaging techniques provide certain advantages.

Clinic 59

Clinic Provider IT Electronics 59

FDA Law Blog

FEBRUARY 28, 2023

FDA announced on October 3, 2022 that the voluntary electronic Submission Template And Resource (eSTAR) templates would be required beginning October 1, 2023, as we blogged about here. There are additionally places to provide attachments for test reports and other supporting documents. New Labeling Requirements.

Provider 52

Provider Electronics IT Complication 52

FDA Law Blog

FEBRUARY 15, 2023

FDA is making these updates in part due to recognition that some of the records and reporting requirements are unnecessary to comply with the Electronic Product Radiation Control (EPRC) program (sections 532, 534(a)(1), and 537(b) of the FD&C Act (21 U.S.C. Thus, these regulations apply to a huge variety of products.

Manufacturing 52

Manufacturing Electronics Medical Clinic 52

FDA Law Blog

JULY 7, 2021

In March 2020, FDA issued a final rule that banned the use of Graduated Electronic Decelerators (GEDs) to treat patients with severe self-injurious and aggressive behaviors (SIB/AB), but did not restrict the use of these same devices for other purposes, like smoking cessation. Circuit Court of Appeals to overturn the ban.

Medical 52

Medical Patient-Centered Patients IT 52

FDA Law Blog

MARCH 20, 2022

The Guidance provides detail on a recalling firm’s responsibilities, preparations, and communications and how the Agency can assist a firm with carrying out its recall responsibilities. The Guidance provides practical guidelines for both firms and direct accounts. Product coding (e.g.,

Electronics 40

Electronics Manufacturing Provider IT 40

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. Integration of Person-Centered Narratives Into the Electronic Health Record: Study Protocol.

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

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.

IT 126

IT Patient-Centered Illness Education 126

FDA Law Blog

JULY 7, 2024

The guidance restates the central premise of the final rule, i.e., that LDTs are medical devices and the clinical laboratories that design, manufacture and use them to test patient specimens are manufacturers. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

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.

IT 105

IT Patient-Centered Healthcare Illness 105

FDA Law Blog

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. 21 U.S.C. §

Medical 64

Medical Manufacturing Electronics Provider 64

PEMBlog

MARCH 27, 2024

She aims to become a physician-scientist in pediatrics and medical genetics, engaging in bench-to-bedside research that utilizes multi-omics-based approaches to provide a molecular diagnosis and support personalized care for individuals with suspected rare genetic diseases and their families.

Consulting 59

Consulting Individual Families Family 59

GeriPal

SEPTEMBER 19, 2024

Give too much, it may cause harm (even if the higher dose had no significant side effects, it would require patients to take a lot of unnecessary additional pills as well as increase the cost.) So, what is the effective dose of palliative care? Give too little – it may not work. This is Eric Widera. Jennifer 04:25 I can take that on.

Patient-Centered 119

Patient-Centered IT Patients Hospital 119

FDA Law Blog

MAY 21, 2024

The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. Public comments must be submitted electronically or postmarked on or before July 22, 2024, 60 days after publication in the Federal Register. 44,597 (May 21, 2024). 21 U.S.C. §

Physicals 69

Physicals Medical Clinic Emergency Room 69