FDA Law Blog

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

Manufacturing 71

Manufacturing Management Specialization Provider 71

PEMBlog

JUNE 14, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. These articles will take another look at the content included in this episode. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources.

Mental Health 98

Mental Health Management Patient-Centered Illness 98

PEMBlog

MAY 31, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. These articles will take another look at the content included in this episode. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources.

Management 89

Management Patient-Centered Finance Transportation 89

FDA Law Blog

MARCH 6, 2024

More information about the conference can be found here. For complete information on the conference, click here. We can offer our readers a special discount for the event. FDA Law Blog readers can use discount code S10-866-866L24.S S for reduced registration fees. Use the discount code S10-676-676L24.S

Management 59

Management Manufacturing Specialization Government 59

Permanente Medicine

MAY 20, 2025

Contributing to this challenge is the exponential growth of information, an expanding population of older adults, and office visit documentation. Information is coming at clinicians, whether they be doctors, nurses, pharmacists, faster than ever, and there is a transparency that exists around us.

Patient-Centered 52

Patient-Centered Patients IT Medical 52

PEMBlog

MAY 17, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. These articles will take another look at the content included in this episode. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources.

Patient-Centered 68

Patient-Centered Mental Health Management Finance 68

FDA Law Blog

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Mallory , 988 F.3d 3d 730 (4th Cir. The case law on commission-based marketing agentsincluding the Sorensen decisionfollow in a similar vein. Marchetti , 96 F.4th

Referral 59

Referral Relationship Government Healthcare 59

FDA Law Blog

JULY 2, 2024

Claud — Among the tools that the government has to enforce the FDC Act is the injunctive power granted by Congress in 21 U.S.C. § While she agreed with the decision here, she did not join in the Court’s decision that the traditional pillars of equity apply in all cases where a special statute provides for injunctive relief.

Provider 52

Provider Specialization Government IT 52

FDA Law Blog

OCTOBER 25, 2021

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

Manufacturing 52

Manufacturing Specialization Government IT 52

FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation. 21 U.S.C. §

Management 52

Management Manufacturing Specialization IT 52

FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation. 21 U.S.C. §

Management 40

Management Manufacturing Specialization IT 40

GeriPal

JULY 19, 2024

I don’t have access to change the levers of government. And either of those could be given to the patient or an informant. Anna 43:15 I mean, yeah, as I’ve had, I think in general, primary care doesn’t have a lot of information about how to use these things. Ana chodos, what should I be? But I don’t.

Screening 119

Screening Primary Care Patient-Centered IT 119

ABIM

JUNE 4, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. See the discussion on the Special Consideration IMG (International Medical Graduates) Pilot Pathway below.) Community Practice in ABIM Governance* Erica N.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier for both physicians and the public to find information. Community Practice in ABIM Governance* Erica N. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

MAY 30, 2025

Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier to find information for both physicians and the public. Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. Community Practice in ABIM Governance* Erica N.

Board-Certified 40

Board-Certified Government Internal Medicine Private Practice 40

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. This region governs essential behaviors like the circadian clock, sleep, energy balance , and feeding.

Provider 109

Provider Medical Complication Diabetes 109

Physician's Weekly

JUNE 23, 2025

Residents of East Palestine, Ohio, where the derailment occurred, have pressed the government to do more to answer questions about the mental and physical health effects of the disaster — from post-traumatic stress to cancer. We desperately need real medical support.” SOURCE: CNN, June 23, 2025 Copyright © 2025 HealthDay.

Community 52

Community Asthma Engineering Family 52

PEMBlog

MAY 24, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. These articles will take another look at the content included in this episode. Department of Health and Human Services (HHS) as part of an award (U07MC37471) totaling $3M with 0 percent financed with nongovernmental sources.

Management 54

Management Patient-Centered Physicals Finance 54

GeriPal

MARCH 24, 2023

It’s going to be published as a special report in JPM I hope in May with as of today, 279, I think HPM physician colleagues, signatures including 21 of the living past presidents of the academy. As somebody who has been part of literally more non-profits than I can remember, non-profit governance structures is a pain in the ass.

IT 113

IT Provider Patients Families 113

Doctors for America

MAY 5, 2025

FOR IMMEDIATE RELEASE Doctors for America PO Box: 21161 2300 18th St NW Lbby Washington, DC 20009-9996 May 5, 2025 Doctors, Local Governments File Brief to Defend Reproductive Health Care Privacy Rights Brief Argues that Upending HIPAA Privacy Rights Would Contradict Decades of Established Precedent WASHINGTON, D.C.

Government 52

Government Medical Student Community Patients 52

GeriPal

SEPTEMBER 5, 2024

They have a special skill, and when they see someone who needs it, they need to use it. That makes it really special for them and for me. And it’s not the same, but it does provide information. Eric 42:11 But how much of it is like Winston Churchill, like, democracy is the worst form of government. And I was.

Patients 98

Patients IT Patient-Centered Hospital 98

GeriPal

MARCH 16, 2023

We have two authors, books, op-eds, prolific authors, and today’s podcast is a two-part special. Like in pandemic, I wrote a few articles early on and then when I started working for the city and state, I just stopped and partly was the horrible, horrible, horrible things we were seeing and that the government was doing to older people.

IT 105

IT Healthcare Professional Healthcare Transportation 105

GeriPal

DECEMBER 7, 2023

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there.

Healthcare 129

Healthcare IT Education Community 129

FDA Law Blog

JUNE 21, 2022

This provision adds nothing substantive to the OTC hearing aid regulatory scheme—it merely tells FDA that it has 30 days from enactment of the user fee legislation to issue its final rules governing OTC hearing aids. Directing FDA to issue rules isn’t out of the ordinary.

IT 52

IT Provider Government Patients 52

Doctors for America

MAY 30, 2025

For nearly 40 years, EMTALA has been understood by medical providers and the federal government — including both Democratic and Republican administrations — to require abortion care when that care is needed to stabilize pregnant patients in a medical crisis. DFA teaches physicians and medical trainees how to do advocacy.

Patients 92

Patients Medical Student Patient-Centered Emergency Room 92

GeriPal

DECEMBER 21, 2023

I could walk down the hall and get information. He created fee for service, special fee for depression. Just to let you know, Eric, we have to give the credit to our federal government. Our alliance is governed by a steering committee and we go to them and say what are the areas? I had a supportive spouse. Diane: Yeah.

Patient-Centered 125

Patient-Centered IT Families Family 125

Physician's Weekly

JUNE 12, 2025

Other experts told PolitiFact that the actual numbers could be higher than what the federal government reports, although not as high as Paragon’s estimate. It is funded through a mix of federal and state money and is administered by states under federal government rules. How High Is the Medicaid Improper Payment Rate?

Government 52

Government Provider Insurance IT 52

Doctors for America

JUNE 23, 2025

Doctors for America calls on the administration, Congress, state and local governments, and public health agencies to take the following urgent actions: End ICE collaborations with local law enforcement, Medicaid agencies, and healthcare facilities.

Medical Student 86

Medical Student Mental Health Healthcare Patient-Centered 86

GeriPal

JULY 20, 2023

So recognizing that the public health emergency was going to be declared over and all those temporary waivers were going to expire, the DEA actually put out a request for information about should it go back to life as it was, or should they potentially have some new rules or new flexibilities? We hear that all the time now. Joe: Yeah.

Telemedicine 73

Telemedicine Telehealth Patient-Centered Board-Certified 73

FDA Law Blog

MAY 23, 2025

Newberger Last week, FDA published a Request for Information (RFI) ( here ) seeking input from the public on its efforts to to identify and eliminate outdated or unnecessary regulations. It is therefore surprising that nearly a month or more has passed for four of these five de novos without any information being posted. By Allyson B.

Manufacturing 59

Manufacturing Specialization IT Provider 59

Physician's Weekly

JUNE 12, 2025

More than 10 million people were automatically reenrolled in their coverage for the 2025 plan year, with their eligibility for tax credits confirmed via a system that allows ACA marketplaces to check government or other data sources. The House bill would end that, requiring documentation before receiving tax credits.

Insurance 52

Insurance Family Families Government 52

Doctors for America

APRIL 29, 2025

The individuals terminated were responsible for everything from regulating the use of artificial intelligence (AI) in medical devices, overseeing and enforcing postmarket studies, updating drug labels to include important safety information, and monitoring drug shortages.

Medical Student 52

Medical Student Patients Medical Individual 52