FDA Law Blog

MARCH 12, 2023

These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. By almost all accounts, these exemptions also improved prescribing and dispensing of medication to patients that need them. John will present on considerations and his learned perspective for the future of teleprescribing.

Telemedicine 98

Telemedicine Government Patients Medical 98

Medical Xpress

APRIL 7, 2023

The United States government is considering a national ban of TikTok, a social media application used by over 150 million Americans. Although the primary reason for the ban is privacy concerns, it presents an opportunity to consider other potential risks.

IT 75

IT Government 75

Medical Xpress

APRIL 5, 2023

We often express our thoughts in words to communicate ideas, present arguments or make decisions. images) or by structures and rules similar to those governing language. images) or by structures and rules similar to those governing language. But what format and structure do these thoughts take in the brain?

Government 76

Government IT 76

Family Physicians of St. Joseph

SEPTEMBER 25, 2018

However, in 2016 they began to realize that the rules and oversight from insurance companies and government entities were creating an environment that took the focus of physicians away from the patients and onto their computers and the completion of irrelevant busywork. They volunteer as the attending physician for high school football games.

Family Physician 52

Family Physician Family Families Primary Care 52

The Clinical Problem Solvers

NOVEMBER 22, 2021

Episode Learning Objectives: After listening to this episode learners will be able to… Understand the historical and present-day role of settler colonialism behind health disparities in Indigenous populations. This includes being mindful of language and the etiology of the words we use in academic and medical spaces (e.g., “low

Community 52

Community Patient-Centered Medical Student Medical 52

FDA Law Blog

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Scope Part 2 —Is reimbursement under Medicaid a grant of funds by the federal government, such that they are governed by the Act? House of Representatives ( H.B.

Manufacturing 102

Manufacturing Government Consulting IT 102

FDA Law Blog

OCTOBER 8, 2023

HPM’s Presentation Deck and recording of the presentation are here, and here (passcode Bv3*o^i5). DEA next hosted Telemedicine Listening Sessions on September 12 and 13, 2023, for which it receive over 180 requests to present. DEA received a whopping 38,000 (!) comments on the two proposed rules. 69,879, 69,880 (Oct.

Telemedicine 64

Telemedicine Relationship IT Mental Health 64

FDA Law Blog

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. Walsh’s unique perspectives on navigating the challenges and opportunities presented by advertising and promotion regulations worldwide.

Government 59

Government Provider Medical 59

FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64

Clinic Clinical Practice Provider Utilities 64

FDA Law Blog

SEPTEMBER 22, 2022

The JAMA editorial notes that there are few Park cases for two primary reasons: [The government] may lead. The drug and medical device industries present particularly compelling arenas in which to pursue deterrence through such prosecution because misconduct can carry high levels of public risk.

Private Practice 59

Private Practice Government Individual Specialization 59

PEMBlog

MAY 17, 2023

Most children who present to Pediatric Emergency Departments these days with mental health concerns – including agitation – have a known psychiatric problem or diagnosis. Why then do we persist with the “is it medical/organic or psych” question? Government.

Patient-Centered 68

Patient-Centered Mental Health Management Finance 68

Tiny Physician

FEBRUARY 15, 2022

However, the core problem in our medical system is yet to be addressed which actually results in these unfortunate incidents. Only very few hospitals and medical colleges have Public Relations Officers (PROs) at all the ICUs and major wards to talk with the patients and to sort out these problems.

Patient-Centered 52

Patient-Centered Government Referral Hospital 52

FDA Law Blog

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. Inside Building 66 Upon arriving at Building 66, all visitors must present government-issued photo identification for check-in. Be ready with backup options (e.g.,

Screening 59

Screening Transportation Provider Electronics 59

ABIM

MAY 18, 2025

I now know that the symptom I initially presented with—perianal fistulas—was a hallmark of Crohn’s disease. Without a full understanding of the disease context, he recommended surgery that, in hindsight, was not the medically appropriate next step. During that time, I endured two debilitating surgeries.

Diagnose 40

Diagnose Healthcare Diagnosis Physicals 40

BMJ

JULY 17, 2020

7 Moreover, medical professionals, health practitioners, and relevant academic institutions should proactively disseminate creditable news and information during such health outbreaks through mainstream social media channels. 新冠肺炎疫情报道中的信息呈现与媒体表现 [Information presentation and media performance during the COVID-19 outbreak].

Community 40

Community Individual Physicals Finance 40

FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic also deeply impacted how industry and the government conduct their operations. The pandemic also deeply impacted how industry and the government conduct their operations. However, not all changes are forever.

Relationship 53

Relationship Government Screening Medical 53

FDA Law Blog

APRIL 24, 2024

The meetings have presented a mix of views with some organizations meeting with OMB being in favor of FDA regulation and others being very much opposed.

IT 59

IT Government Community Management 59

GeriPal

JULY 19, 2024

We didn’t have medications that were effective with a few side effects. I heard this beautiful thing the other day, which was to an electronic medical record, I am not a whole person. As my colleague mentioned, I am not a whole person to my medical record, I am a collection of codes. We’re very datified.

Screening 119

Screening Primary Care Patient-Centered IT 119

FDA Law Blog

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. befitted a very important pathway to market for novel medical devices. FDCA § 513(f)(5).

Manufacturing 52

Manufacturing Specialization Government IT 52

The Clinical Problem Solvers

AUGUST 25, 2020

Trainees may use this foundation to question how this might impact their medical education and think about this educational legacy may be reformed through curricular and structural changes at their institutions. Trainees We encourage trainees to reflect on the ways they have been socialized to learn and think about racism in our country.

Community 52

Community Patient-Centered Relationship Education 52

FDA Law Blog

JUNE 27, 2024

Coconut Grove had noted “verified” on the prescriptions which DEA found “is not sufficient to identify and resolve any red flags that may be present.” Alternating Between Cash and Insurance According to the government’s expert, patients paying for prescriptions with insurance and for others with cash is a red flag for those paid with cash.

Insurance 52

Insurance Patients Utilities Chronic Condition 52

FDA Law Blog

APRIL 23, 2021

The question presented is whether this statutory language authorizes the Commission to seek, and a court to award, equitable monetary relief such as restitution or disgorgement. Section 518(e) authorizes FDA to mandate refunds to persons who FDA believes have been damaged by a violation involving medical devices. 592, 15 U.

Government 40

Government IT Transportation Provider 40

FDA Law Blog

MARCH 20, 2022

Baumhardt, Senior Medical Device Regulation Expert & Anne K. Most FDA-regulated entities have an established SOP that governs the evaluation, decision, notification, and process for conducting a recall. By Philip Won & Lisa M.

Electronics 40

Electronics Manufacturing Provider IT 40

FDA Law Blog

AUGUST 17, 2022

We note, however, that some of the most important clarifications are not codified in the actual rule but are presented in the Preamble; thus, while FDA currently plans to interpret the rule as it states in the Preamble, it is not bound to do so. The preemption provisions, for example, have not changed.

Provider 40

Provider Manufacturing IT Government 40

ABIM

JUNE 4, 2025

See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Dr. McDonald spoke about ABIM’s work engaging early career physicians (those who earned initial certification within the last 10 years), including presentations and listening sessions at recent national meetings.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

This is now being reviewed by the American Board of Medical Specialties, which oversees ABIM. Community Practice in ABIM Governance* Erica N. IDSA has also been hosting member forums to maintain public access to evidence-based guidelines no longer available through government institutions.

Board-Certified 52

Board-Certified Government Community Education 52

Tiny Physician

DECEMBER 11, 2021

The PG doctors strike has entered its 12th day at the time of publishing this article and it has badly affected the patient care at the Government Medical Colleges (GMCs). At any given point in time, three batches of junior residents (PG doctors) will be present in the medical colleges.

Patients 52

Patients Government Appointment Finance 52

ABIM

JUNE 24, 2025

The group discussed policy shifts and potential implications for graduate medical education and health equity. Dr. McDonald acknowledged that recent executive orders have emphasized more competition in medical and legal education accreditation, but reaffirmed ABIM’s commitment to evidence-based practice and health equity.

Board-Certified 40

Board-Certified Board-Certified Physicians Government Community 40

Physician's Weekly

JUNE 16, 2025

MONDAY, June 16, 2025 (HealthDay News) — In a policy statement issued by the American Academy of Pediatrics and published online June 16 in Pediatrics , updated recommendations are presented for providing adolescent patients with contraceptive counseling and methods. ” Abstract/Full Text Copyright © 2025 HealthDay.

Patient-Centered 52

Patient-Centered Education Electronics Insurance 52

The Clinical Problem Solvers

OCTOBER 11, 2021

In contrast, de jure segregation refers to the involvement of federal, state, and local governments in creating, structuring, designing, reinforcing, and perpetuating segregation. Episode Takeaways: 1. This reality of de jure segregation helps us understand that we have an obligation to remedy this constitutional violation.

Government 52

Government Community Education Individual 52

ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. One notable trend was a higher representation of international medical graduates and osteopathic physicians in the specialty. Community Practice in ABIM Governance* Erica N.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

The Clinical Problem Solvers

FEBRUARY 14, 2022

Hosted by team members Naomi Fields and LaShyra Nolen,our guests present their community-based work in Pennsylvania and lay bare the connections between race, place, and health. Our ancestors considered our present to be impossible, so how can we use our ideas and experiences to effect positive change in our communities?

Community 52

Community Individual Mental Health IT 52

FDA Law Blog

OCTOBER 17, 2023

Compared to the previous version, the new guidance document highlights that the Breakthrough Devices Program may also be applicable to certain devices that benefit populations impacted by health and/or healthcare disparities and to certain non-addictive medical products to treat pain or addiction. By Philip Won & Lisa M.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law Blog

AUGUST 3, 2022

These products are subject to the same regulatory requirements as any unapproved medical device”). It came 16 years after Congress passed the Medical Device Amendments of 1976, without saying a word about FDA authority over laboratory testing. See AdvaMed Welcomes Senate Committee Passage of MDUFA V Legislation (June 15, 2022).

Lab Testing 98

Lab Testing Government IT Manufacturing 98

GeriPal

NOVEMBER 17, 2022

AlexSmithMD (still on Twitter at present). Sheryl: Largely the people who live there as opposed to government funds. You’re independent, drive in and out, and the more help you need, so for example, now you need somebody to help with medication administration. Transcript. Eric: Welcome to the GeriPal podcast.

Community 97

Community IT Mental Health Medical 97

GeriPal

JANUARY 20, 2023

There have been multiple subsequent government reports on nursing home care, most recently was about eight, nine years ago from the OIG. Part of it’s what Mike was saying, it’s accountability as a country, as a nation and as the government. From a medical director standpoint, how do you think about that?

Finance 95

Finance Board-Certified IT Provider 95

Tiny Physician

MARCH 30, 2022

The bystanders of the patient who were present at that time understood the efforts taken by the doctors and told the treating team that the doctors did their best and it was the patient’s fate. Is this a case of medical negligence? Therefore, a case of medical negligence will not stand, let alone murder charges.

Hospital 52

Hospital Government Patient-Centered Medical 52