FDA Law Blog

APRIL 6, 2025

Andrew draws on his government experience investigating and prosecuting violations of the FDC Act, the Controlled Substances Act, the False Claims Act, and other federal healthcare laws to now represent clients facing those issues. During law school, Julie obtained practical litigation and transactional experience.

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IT Nurse Practitioner Patient-Centered Government 59

Georgetown Pediatrics & Family Medicine

MAY 11, 2022

If you have any concerns about your baby’s nutrition, please talk with your pediatrician. What if baby formula is out of stock everywhere I look? Check smaller stores and drug stores, which may not be out of supply when the bigger stores are. If you can afford it, buy formula online until store shortages ease. Check social media groups.

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Supply Chain Specialization IT Family Medicine 52

PEMBlog

JUNE 7, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about what prehospital providers should do to get these agitated children safely to the ED.

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Transportation Patient-Centered Management Finance 122

FDA Law Blog

MARCH 7, 2024

Led by Annie Kennedy, Everylife’s VP of Government Affairs and Policy, we worked the halls of Congress to educate lawmakers on the pressing needs of the rare disease community. In non-leap years we celebrate on February 28 or March 1. Last Wednesday, the White House hosted its first ever rare disease event.

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Government Community Specialization Education 69

FDA Law Blog

SEPTEMBER 22, 2022

The JAMA editorial notes that there are few Park cases for two primary reasons: [The government] may lead. While strict liability criminal statutory schemes are an exception to that rule, we don’t agree that the government should bring a Park case just because it can.

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Private Practice Government Individual Specialization 59

Minnesota Academy of Family Physicians

MARCH 27, 2025

The bill passed by a voice vote and was referred to the State and Local Government Committee. This will trigger a special election in District 6. SENATE HEALTH AND HUMAN SERVICES (HHS) COMMITTEE On Tuesday, March 18, 2025, the Senate HHS Committee heard a series of health care bills: S.F. Read a summary of S.F.

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Family Physician Insurance Finance Individual 52

FDA Law Blog

FEBRUARY 18, 2025

While on paper the respective credentials of each of the experts would indicate a balance of authority, or maybe even weigh in favor of the pharmacys expert (DEAs expert had prior disciplinary history), the ALJ and DEA Administrator each found the testimony of the governments expert more credible. Whats the take away?

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Government Specialization Patients IT 69

FDA Law Blog

MAY 4, 2025

1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. The government determined that the chemicals had been imported into the U.S. The government alleged that IMC Pro entered into business agreements with companies operating in China.

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Manufacturing Government Specialization IT 52

Blood, Sweat, and Tears

MAY 24, 2022

You have to be able to laugh at situations, the system, the government, people and especially yourself (Mostly yourself). But What broke the monotony was a special nurse with a special personality who I laughed my head off with during every call. I guess it’s necessary as a coping mechanism. I’m not sure why.

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Referral Community Patients Specialization 52

Permanente Medicine

MAY 20, 2025

” Related AI scribes story: Analysis: AI scribes save physicians time, improve patient interactions and work satisfaction Dr. Nguyen also highlighted the potential to utilize artificial intelligence and Kaiser Permanente’s extensive medical database to develop predictive analytic models aimed at enhancing patient care.

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Patient-Centered Patients Medical IT 52

PEMBlog

JUNE 14, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about what we should consider when boarding children in the ED for mental health reasons.

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Mental Health Management Patient-Centered Illness 98

FDA Law Blog

OCTOBER 24, 2023

FDA recommends that firm-generated portions of an SIUU communication should use “plain language,” as despite having specialized training, “research indicates that HCPs may nonetheless have difficulty understanding some types of scientific information, including clinical trial data, and the design and methodological limitations of studies.”

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Clinic Clinical Practice Provider Utilities 64

PEMBlog

MAY 31, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate pharmacologic management strategies for agitated children.

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Management Patient-Centered Finance Transportation 89

FDA Law Blog

FEBRUARY 13, 2025

In fact, eSTAR does not allow a PCCP to be included in a Special 510(k); attempting to do so results in the message if you are establishing a PCCP this should not be done in a Special 510(k). In such cases, performance testing may be conducted again.

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Manufacturing Management Specialization Provider 71

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. Medicare or Medicaid). OIG reviews non-safe harbored arrangements on a case-by-case basis. In contrast to its decision in United States v. Polin , 194 F.3d 3d 863 (7th Cir.

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Referral Relationship Government Healthcare 59

PEMBlog

MAY 17, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. Why then do we persist with the “is it medical/organic or psych” question? It is also episode 1 in a 5 episode series focused on agitation in children and adolescents.

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Patient-Centered Mental Health Management Finance 68

GeriPal

JULY 19, 2024

Summary Transcript Summary The US Preventive Services Task Force (USPSTF) concluded back in 2000 that there is insufficient evidence to recommend for or against routine screening for dementia in older adults. Are there, though, populations that it may be helpful in, or should that change with the advent of the new amyloid antibodies? Should it?

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Screening Primary Care Patient-Centered IT 120

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

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Manufacturing Government Specialization IT 52

FDA Law Blog

JUNE 7, 2023

The cases were both brought under the False Claims Act (FCA), the Civil War-era law that the government uses to claw back funds it pays out to parties that overbill federal programs. The FCA incentivizes whistleblowers to come forward by awarding them a cut of any recovery. What was SuperValu all about?

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Government Patient-Centered IT Manufacturing 40

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.

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Provider Government Specialization IT 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. Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week.

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Consulting Provider Manufacturing Government 52

FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution. The discount code is: S10-826-826L24.S.

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Private Practice Government Specialization Management 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.

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Management Manufacturing Specialization IT 52

FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. DEA regulations require “adequate security” but do not specially require cameras in health care facilities. Department of Justice (“DOJ”), Sovah Health to Pay United States $4.36

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Board-Certified Provider Government Management 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.

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Management Manufacturing Specialization IT 40

FDA Law Blog

SEPTEMBER 30, 2022

The controversy over the FCA’s intent standard where the applicable statute or regulation is ambiguous has special relevance when the FCA is used to target inaccurate government price calculations. The relator has until December 22, 2022 to petition for certiorari to the Supreme Court. of America v.

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Insurance Manufacturing Government Specialization 40

ABIM

JUNE 4, 2025

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

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Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

Community Practice in ABIM Governance* Erica N. Erin Bonura, MD, Chair, ABIM Infectious Disease Board The Infectious Disease Board , which meets twice a year and is responsible for oversight of ABIM policy and assessment in the specialty, held its spring meeting on March 25, 2025.

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ABIM

MAY 30, 2025

Lieske, MD , raised concerns about how new government policies may affect international medical graduates and health equity work at ABIM. Expanding ABIM’s engagement with stakeholder communities such as early career physicians, specialty societies and patient-focused organizations. Rodriguez, MD , Chair of the Nephrology Board, and John C.

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Board-Certified Government Internal Medicine Private Practice 40

FDA Law Blog

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.” GSK skinny label case , the U.S.

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Government Manufacturing IT Utilities 72

GeriPal

MARCH 24, 2023

For others, this piece, while painful to read, gave voice to what they have been feeling over the last decade – hospice has in some ways lost its way in a quest of promoting profit over care. If you are interested in signing the position statement “Core Roles and Responsibilities of Physicians in Hospice Care”, click here. Is it you, Ira?

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IT Provider Patients Families 115

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.

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Provider Medical Complication Diabetes 110

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. Allison also praised the decision to involve the community in shaping the research.

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Community Asthma Engineering Complication 52

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.

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Supply Chain Manufacturing Government Hospital 59

PEMBlog

MAY 24, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Government. This podcast episode hosted by Brad Sobolewski ( @PEMTweets ) and co-authored by Dennis Ren ( @DennisRenMD ) is all about age-appropriate non pharmacologic management strategies for agitated children.

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Management Patient-Centered Physicals Finance 54

GeriPal

SEPTEMBER 5, 2024

But before we go into all of that, I think, Bill, you have a song request for Alex. Bill 01:52 I do. Bill 01:53 Alex asked me for a song that was resonating in my head at the time, and it would be Guy Clark’s song, T he Cape. Eric 02:01 Why guy Clark’s the Cape? Bill 02:03 Oh, it’s a long story. I’ll make sure. Here we go.

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Patients IT Patient-Centered Hospital 98

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.

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