ABIM

JUNE 17, 2025

Reau, MD Dr. Reau is ABIM Board Certified in Gastroenterology and Transplant Hepatology, specializing in viral hepatitis. I also decided to enroll in the Internal Medicine LKA, as I had let that certification lapse, and then switched to the inpatient version when that became available in 2024. By Nancy S.

Internal Medicine 40

Internal Medicine Board-Certified Patient-Centered Specialization 40

FDA Law Blog

APRIL 25, 2023

Special 510(k)s. If a firm wants to add an additional cyber feature to a currently non-cyber device that is already authorized for commercial distribution through 510(k) clearance or a De Novo classification request, the firm needs to determine if the change can be submitted as a Special 510(k). 510(k) exempt.

Specialization 105

Specialization Provider Medical Manufacturing 105

FDA Law Blog

JULY 17, 2024

Earlier this month the FDA announced the first meeting of the GeMDAC will be held on August 2, 2024 to discuss a novel treatment for Niemann-Pick disease type C (and Frank and James are looking forward to being there!). By Sarah Wicks & James E. Valentine & Frank J.

Patient-Centered 105

Patient-Centered Community Medical Specialty Clinic 105

Noreta Family Medicine

JANUARY 29, 2024

The DEA has a nice website where you can search for year-round controlled medicine drop off sites: [link] The DEA also has two “take back” days per year, with the next one set for Saturday, April 27, 2024. Accessed via [link] 3) To get rid of used needles – These require special attention!

Primary Care Doctor 52

Primary Care Doctor Family Physician Primary Care Families 52

Sound Physicians

NOVEMBER 5, 2024

Led by specially trained medical, team leadership is armed with the tactical knowledge needed to drive high-quality care and highly effective practice management. Sound also supports residency programs, which guarantee a consistent pool of new critical care clinicians who can provide support in the ICU.

Management 52

Management Hospital Telemedicine Board-Certified 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

FDA Law Blog

JANUARY 4, 2024

As such, we can offer our readers a special 10% discount off the current price tier for the event. To obtain a copy of the conference brochure and to register for the event, please visit ACI’s website – here. FDA Law Blog is a conference media partner for this event. The discount code is: S10-826-826L24.S.

Private Practice 52

Private Practice Government Specialization Management 52

FDA Law Blog

JANUARY 24, 2024

The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. As such, we can offer our readers a special 10% discount. FDA Law Blog is a conference media partner.

Specialization 59

Specialization Provider IT Medical 59

FDA Law Blog

OCTOBER 2, 2024

We find it surprising that a PCCP may not be submitted with a Special 510(k), given a Special 510(k) may be used to modify an existing device where well-established methods are available to evaluate the change. FDA, Guidance for Industry, The Special 510(k) Program (2019).

Medical 59

Medical Specialization Manufacturing IT 59

FDA Law Blog

MARCH 7, 2024

Given the energy and progress accomplished each year at this special time, anyone want to second a motion that the entire month of February become dedicated to the support of rare diseases? Photo from February 28, 2024, White House Rare Disease event (from left to right: Frank Sasinowski, Christina Hochul, Paul Melmeyer)

Government 69

Government Community Specialization Education 69

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. Accessed 2024. Diversifying your mental health outreach goes hand in hand with diversifying your providers. Ring the Alarm. The Crisis of Black Youth Suicide in America.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

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. . § 314.93 , an applicant that wants to submit such an ANDA “must first obtain permission from FDA to submit such an ANDA.”

Specialization 59

Specialization IT 59

Physician's Practice

JUNE 23, 2025

This April 2024 article by Neil Baum, MD , on hiring a marketing consultant gives this tip: 3. These professionals typically have specialized knowledge of the healthcare industry and stay informed on the latest trends and regulations in healthcare marketing.

Consulting 52

Consulting Management Private Practice Diabetes 52

FDA Law Blog

DECEMBER 2, 2024

The ISO 10993-1: 2018 standard, in turn, describes contact duration as the cumulative sum of single, multiple, or repeated duration of contact, although we are aware that a draft version of the standard (ISO/DIS 10993-1:2024) may be heading in a similar direction to the draft guidance.

Consulting 52

Consulting Medical Management Specialization 52

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. As that may develop, the 2024 edition of this conference will be worth coming back for.

Consulting 52

Consulting Manufacturing Provider Government 52

The Motivated MD

OCTOBER 10, 2024

I am not liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. Best Index Funds Several investment platforms (Vanguard, Fidelity, Charles Schwab, USAA, etc.) offer index funds with low expense ratios.

Finance 52

Finance Individual Management IT 52

PEMBlog

OCTOBER 18, 2024

Duchenne Muscular Dystrophy (DMD) is a complex and progressive disease requiring highly specialized care, especially in emergency situations. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. The condition affects multiple organ systems—muscular, cardiac, and respiratory—leading to a myriad of clinical complications.

Patients 52

Patients Complication Management Consulting 52

FDA Law Blog

NOVEMBER 20, 2024

It is recommended to submit a Pre-Submission to the Agency when considering your chemical characterization strategy, especially for any devices/materials with special considerations or use of alternative strategies and solvents. FDA is extending the comment period on the notice published September 20, 2024 ( 89 FR 77162 ).

Provider 59

Provider Medical Manufacturing Consulting 59

FDA Law Blog

MAY 7, 2025

2024) , which affirmed Marchettis conviction for receiving illegal kickbacks but determined that most of his actions did not violate the AKS. In the absence of such evidence, the Court held that Sorensens volume-based (i.e., percentage-based or per-lead) compensation structures did not violate the AKS. Marchetti , 96 F.4th 4th 818 (5th Cir.

Referral 59

Referral Relationship Government Healthcare 59

PEMBlog

AUGUST 20, 2024

eCPR is typically performed in specialized centers with highly trained personnel in well coordinated teams. Listen ECPR – PEM Currents: The Pediatric Emergency Medicine Podcast – by: Brad Sobolewski, MD, MEd [link] Subscribe Apple Podcasts Spotify YouTube References Gajkowski EF, Herrera G, Hatton L, et al. 2022; 68:133–152.

Patient-Centered 52

Patient-Centered Hospital Patients IT 52

FDA Law Blog

OCTOBER 6, 2023

However, meeting this timeline would require FDA to issue a final rule within approximately six months of the PR’s publication date—in other words, by April 2024. In addition, FDA proposes to continue to exercise enforcement discretion (i.e.,

Provider 64

Provider Manufacturing IT Medical 64

Medical Xpress

JUNE 16, 2025

A 2024 study published in the journal Nature Medicine found that military veterans with brain injuries saw major mental and physical improvements after just one ibogaine session. Ibogaine is a psychedelic that causes powerful hallucinations and can last for hours. In Brazil, the therapy has helped thousands.

Mental Health 52

Mental Health IT Medical Specialization 52

Annals of Family Medicine

NOVEMBER 20, 2024

Setting or Dataset Twenty-two Colorado primary care practices of varying organizational structure participated from 2022 through 2024. Results Practice types included clinician-owned, FQHCs, and system-owned; most specialized in family medicine (91%, N=22). Population Studied Primary care practice teams. per clinic (SD=6.4)

Primary Care 130

Primary Care Consulting Medical Illness 130

Physician's Weekly

JUNE 19, 2025

The number of nurse practitioners specializing in geriatrics has more than tripled since 2010, increasing the availability of care to the current population of seniors, a recent study in JAMA Network Open found. Their growth has bolstered primary care, and, like doctors, they can specialize in particular branches of medicine.

Nurse Practitioner 52

Nurse Practitioner Families Family Primary Care 52

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

Manufacturing 105

Manufacturing Provider IT Electronics 105

Medical Xpress

JUNE 16, 2025

What is known is that special cells in the eye called intrinsically photosensitive retinal ganglion cells (ipRGCs) detect blue light and send signals to the SCN to reset the clock. But what happens inside the SCN after receiving this light signal has remained largely mysterious—until now.

Provider 110

Provider Medical Complication Diabetes 110

ABIM

JUNE 4, 2025

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) In 2024, 77% of eligible ABIM Board Certified endocrinologists who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. or Canada to become eligible for ABIM Board Certification.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

The Motivated MD

SEPTEMBER 19, 2024

For the better half of 2024, I have been periodically writing posts that are individual articles that double as potential chapters to a future book. The Motivated Resident: An Example In 2024, the current 401(k) contribution limits are $23,000. Not an easy thing to do. However, I often think of it this way.

Finance 52

Finance Individual Education Healthcare Professional 52

Physician's Weekly

JUNE 23, 2025

In 2024, the NIH funded six short-term research projects totaling over $1 million. Allison also noted that the community has also been pushing for an emergency declaration that would give residents access to special Medicare benefits to help pay for medical care tied to chemical exposure, CNN said.

Community 52

Community Asthma Engineering Complication 52

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.” DEA, Palomar Hospital Pays $250,000 for Diverting Fentanyl ( June 3, 2024 ).

Management 59

Management Patient-Centered Hospital Healthcare 59

ABIM

MAY 30, 2025

In 2024, 77% of ABIM Board Certified nephrologists due for an assessment opted for the LKA over the traditional, 10-year MOC exam. Dr. Adey has provided updates to the Nephrology Board about this process at the last two meetings ( fall 2024 and spring 2024 ). Additionally, participation in LKA remains a leading choice.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

Family Physicians of Greeley

JANUARY 9, 2024

This is one small part of why having a physician that is specially trained in navigating this age range is important. The adolescent years can be exciting, but they can also be challenging due to the many physical and emotional changes happening.

Physicals 40

Physicals Family Physician Family Medicine DO 40

ABIM

JUNE 11, 2025

In 2024, 75% of infectious disease physicians who chose an assessment opted for the LKA over the traditional, 10-year MOC exam. This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM.

Board-Certified 52

Board-Certified Government Community Education 52

GeriPal

JANUARY 25, 2024

ABIM MOC credit will be offered to subscribers in November, 2024. So, there was this study called, Acute Care for Elders, where they developed these specialized units and they had specialized attention to multidisciplinary geriatric domains for inpatient hospitalized older adults, and they showed great outcomes.

Patient-Centered 122

Patient-Centered IT Illness Patients 122

FDA Law Blog

APRIL 8, 2024

In its report, Drug Shortages: Root Causes and Potential Solutions, FDA explains that the equipment needed to produce sterile injectables is highly specialized and expensive, meaning that in a shortage situation, production capacity cannot be substantially increased without taking the time and expense of procuring and qualifying new equipment.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

PEMBlog

JULY 10, 2024

Listen Emily Labudde & Brad Sobolewski “Syphilis” PEM Currents: The Pediatric Emergency Medicine Podcast, July 10, 2024 [link] Subscribe Apple Podcasts Spotify YouTube References Emily J. July 2024; 45 (7): 373–380. And I’ve got a special guest host. Pediatr Rev. link] Centers for Disease Control and Prevention.

Patient-Centered 52

Patient-Centered Patients IT Physicals 52

PEMBlog

JANUARY 16, 2025

Updated February 26, 2024. As always, Im your host, Brad Sobolewski, and today were diving into an important topic, inhalant misuse, with a special focus on nitrous oxide. Further complicating matters is that each inhalant has its own special risks. References Perry H, Burns MM. Inhalant misuse in children and adolescents.

Complication 52

Complication Patient-Centered Management Patients 52