FDA Law Blog

APRIL 25, 2023

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. Timeline Section 524B became effective on March 29, 2023. Special 510(k)s. This example suggests that the prospects are poor for adding cyber features via a Special 510(k).

Specialization 105

Specialization Provider Medical Manufacturing 105

Annals of Family Medicine

NOVEMBER 20, 2024

This need became apparent with the initiation of the Alberta Surgical Initiative’s Facilitated Access to Specialized Treatment (FAST). Setting: Alberta, Canada from May 2022 to October 2023. Study Design and Analysis: We used a mixed-method complexity-informed methodology.

Referral 130

Referral Healthcare Provider Utilities 130

FDA Law Blog

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Javitt & Steven J. Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

Medical 119

Medical Patient-Centered Healthcare Specialization 119

Barton Associates

JUNE 19, 2025

Recent data shows that about half of physicians (45.2%) reported symptoms of burnout in 2023 —and according to a 2023 study published in the “Journal of the American Medical Association,” one-third of surveyed doctors considered leaving medicine behind. Why leverage a locum tenens medical staffing network?

Healthcare 52

Healthcare Healthcare Professional Provider Community 52

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. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

Specialization 40

Specialization Clinic Provider IT 40

Medical Xpress

APRIL 24, 2023

A pilot study conducted at Hospital for Special Surgery (HSS) shows evidence that a mid-calf nerve block is a safe and effective regional anesthetic option for foot and ankle surgeries and may enable faster recovery of motor function of the ankle joint compared with a popliteal block.

Specialization 74

Specialization Hospital 74

Medical Xpress

APRIL 24, 2023

In a study conducted at Hospital for Special Surgery (HSS), researchers found that the use of peripheral nerve blocks in total knee and total hip arthroplasty were associated with a consistent reduction in risk for postoperative complications in patients with a lower comorbidity burden.

Patients 73

Patients Complication Specialization Hospital 73

FDA Law Blog

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week.

Consulting 52

Consulting Manufacturing Provider Government 52

Physicians Alliance of Connecticut

APRIL 12, 2025

Bureau of Labor Statistics projects that the field will grow by 15 percent from 2023 to 2033 , which is higher than the average for roles that provide support to healthcare professionals. The need for medical assistants is growing rapidly.

Medical 52

Medical Healthcare Patient-Centered Primary Care Physician 52

Barton Associates

MAY 1, 2025

adults had a mental illness in 2023, and about half (46%) of them did not get any treatment. Nurse practitioners are actually the third-fastest growing occupation in the United States, with a projected 46% growth rate between 2023 and 2033, according to the BLS. But many people are not receiving adequate care—in fact, 23% of all U.S.

Nurse Practitioner 52

Nurse Practitioner Mental Health Behavioral Health Services Provider 52

Barton Associates

MAY 8, 2025

Reducing Burnout Among Permanent Staff Did you know that nearly half of physicians (45.2%) reported at least one symptom of burnout in 2023? Bring specialized skills that might be otherwise lacking among permanent staff. Adapt quickly to new processes, electronic health record (EHR) systems, and more.

Medical Staff 52

Medical Staff Medical Patients Healthcare 52

Physicians Alliance of Connecticut

MAY 27, 2025

Bureau of Labor Statistics projects that employment for medical secretaries and administrative assistants will grow by 5% between 2023 and 2033. More healthcare admin assistants will be needed to handle the office tasks related to getting Connecticut residents the care they need. Is This the Right Career for You?

Healthcare 52

Healthcare Private Practice Electronics Management 52

PEMBlog

JUNE 7, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. These articles will take another look at the content included in this episode.

Transportation 122

Transportation Patient-Centered Management Finance 122

Physician's Weekly

JUNE 19, 2025

When Alyne Diamond fell off a horse in August 2023 and broke her back, her employer-based health plan through UnitedHealthcare covered her emergency care in Aspen, Colorado. It also covered related pain management and physical therapy after she returned home to New York City. The bills totaled more than $100,000.

Insurance 52

Insurance Patient-Centered Government Provider 52

FDA Law Blog

AUGUST 18, 2024

The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use. The classification order identifies the special controls and therefore is extremely important.

Specialization 69

Specialization Hospital Physicals Provider 69

Aspiring Minority Doctor

FEBRUARY 7, 2023

It made me feel so special and loved. This actually took the entire 4 hours, but it was such a beautiful display of gratitude, and I really loved it. It was also during this session where I was surprised with a beautiful birthday card signed by all the ladies in the group.

IT 52

IT Medical Mental Health Patients 52

Plum Health

AUGUST 20, 2023

It also discusses cultural events, the best coffee shops to study, the best parks to relax and unwind, and the best restaurants for a student budget and for when parents or loved ones come to town for a special occasion.

Medical Student 52

Medical Student Community Specialization Medical 52

PEMBlog

MAY 31, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. 2023 Mar 21:S1876-2859(23)00091-8. These articles will take another look at the content included in this episode. Foster AA, Saidinejad M, Duffy S, Hoffmann JA, Goodman R, Monuteaux MC, Li J. Acad Pediatr. doi: 10.1016/j.acap.2023.03.005.

Management 89

Management Patient-Centered Finance Transportation 89

FDA Law Blog

FEBRUARY 27, 2023

That emergency declaration is set to expire on May 11, 2023. While no “special registration” will yet be required to engage in telemedicine prescribing of controlled substances, DEA is proposing parameters to guide the practice of telemedicine encounters in a post-COVID world. 21 U.S.C. § 802(54)(D)(i). 21 U.S.C. § 802(54)(D)(i).

Telemedicine 59

Telemedicine Telecommunication Telehealth Medical 59

Logansport Memorial Hospital

MARCH 7, 2024

But 2023 was a really bad year for me between the infection and everything. Healing chronic wounds at Logansport Memorial’s Wound Care Center The Logansport Memorial Wound Care Center provides specialized treatment, including hyperbaric oxygen therapy, for chronic or non-healing wounds, right here at home.

Patients 52

Patients Patient-Centered Diabetes IT 52

PEMBlog

MAY 17, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. These articles will take another look at the content included in this episode.

Patient-Centered 68

Patient-Centered Mental Health Management Finance 68

FDA Law Blog

OCTOBER 12, 2023

Such an ANDA therefore can be submitted only upon the submission and approval of a special Citizen Petition, called a Suitability Petition. Like with other types of Reviews, FDA will assign a “goal date” to any Suitability Petition submitted after October 2, 2023. covering ANDA Suitability Petitions.

Specialization 59

Specialization IT 59

FDA Law Blog

NOVEMBER 6, 2024

Starting in 2022 with a patent certification requirement, both Jazz and Avadel have sued FDA over this drug, with Jazz most recently bringing suit challenging FDA’s decision that Avadel’s Lumryz (sodium oxybate) is clinically superior to Jazz’s Xywav (sodium oxybate) in 2023. Black Ball Freight Serv. , 532, 539 (1970) (cleaned up).

Clinic 111

Clinic IT Patient-Centered Consulting 111

PEMBlog

JUNE 14, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Pediatrics March 2023; 151 (3): e2022057383. These articles will take another look at the content included in this episode. Coker, Gretchen J. Cutler, Matthew Hall, Rustin B. Morse, Katherine A. Nash, Kavita Parikh, Bonnie T.

Mental Health 98

Mental Health Management Patient-Centered Finance 98

FDA Law Blog

JULY 17, 2024

In December 2023, FDA established the Genetic Metabolic Diseases Advisory Committee (also called “GeMDAC,” which we blogged about here ) to advise FDA regarding treatments for genetic metabolic diseases (i.e., those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

FDA Law Blog

NOVEMBER 5, 2023

The 14th Asia Pacific Symposium on Cochlear Implant and Related Sciences is poised to captivate the global scientific community from November 8-11, 2023, as it convenes in Seoul, Korea. Philip Won , of Hyman, Phelps & McNamara, P.C.

Engineering 52

Engineering Specialization Community Medical 52

Aspiring Minority Doctor

DECEMBER 30, 2022

I'm just seriously so blessed to have such an amazing daughter and I'm even more so grateful that I was able to spend her special day with her and celebrate in a way that she wanted. I am excited for 2023 and for the wild ride I'm sure it will take me on.

Specialization 52

Specialization IT Individual Patients 52

The Clinical Problem Solvers

NOVEMBER 3, 2022

He has a passion for both clinical and academic neurology and will be starting neurology residency in the summer of 2023. He has special interests in neurophysiology, autoimmune neurology, and neuroimmunology, but is excited about all neurological fields.

Medical Student 52

Medical Student Internal Medicine Insurance Specialization 52

The Clinical Problem Solvers

MARCH 14, 2025

These programs recognize the increasing difficulties in having to first see a community-based primary care provider before seeing a specialized psychiatrist. 2023 Apr;21(2):166-7. Diversifying your mental health outreach goes hand in hand with diversifying your providers. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

MAY 4, 2023

Section 3606(a) of the Food and Drug Omnibus Reform Act (FDORA) directed FDA to “issue or revise draft guidance that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices,” not later than December 29, 2023. DHTs include monitoring instruments (e.g.,

Clinic 59

Clinic Telehealth Provider Electronics 59

The Clinical Problem Solvers

DECEMBER 16, 2020

Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology [published correction appears in J Am Coll Cardiol. 2010;363(7):609-619. 2019 Jun 25;73(24):3234]. J Am Coll Cardiol.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. Updated 2023 Jul 10]. The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications. Pediatrics. 2018 Oct;142(Suppl 2):S72-S81.

Patients 52

Patients Complication Management Consulting 52

FDA Law Blog

MAY 8, 2023

Industry stakeholders seeking to provide feedback to FDA can submit comments to Docket: FDA-2022-D-2628 by July 3, 2023.

Manufacturing 98

Manufacturing Provider Medical IT 98

PEMBlog

APRIL 20, 2023

A special thanks to Dr. Cristina Tarango, director of the Hemophilia Treatment Center at Cincinnati Children’s and Lisa Littner, Project Manager at Cincinnati Children’s who helped me research and write this post. Epub 2023 Jan 16. Epub 2021 Oct 10. PMID: 34628693. Adv Clin Chem. 2023;113:273-315. doi: 10.1016/bs.acc.2022.12.001.

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law Blog

FEBRUARY 22, 2023

as a de novo special control or in a guidance document for a specific device type). Comments on the draft guidance are due on or about March 8, 2023. For example, if a critical task is introduced or impacted does that trigger the need for a new 510(k)?

Manufacturing 64

Manufacturing Engineering Medical IT 64

PEMBlog

AUGUST 20, 2024

2023; 187:109792. eCPR is typically performed in specialized centers with highly trained personnel in well coordinated teams. Rationale and methods of the advanced R2Eperfusion STrategies for refractory cardiac ARREST (ARREST) trial. Am Heart J. 2020;229:29–39. Bartos JA, Yannopoulos D. Resuscitation.

Patient-Centered 52

Patient-Centered Hospital Patients IT 52

FDA Law Blog

OCTOBER 6, 2023

Call for Comment Despite the significant potential impact of the PR for a wide array of stakeholders, and the many questions it raises, comments must be submitted no later than December 4, 2023—just 60 days after the PR’s issuance. In addition, FDA proposes to continue to exercise enforcement discretion (i.e.,

Provider 64

Provider Manufacturing IT Medical 64