PEMBlog

JUNE 7, 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.

Transportation 123

Transportation Patient-Centered Management Finance 123

Minnesota Academy of Family Physicians

MARCH 13, 2025

Meanwhile, Democrat David Gottfried ‘s win in the Roseville special election has tied the Minnesota House (67 Republicans, 67 Democrats), shifting the balance of power and influencing which bills move forward in coming weeks. Committee Hearing Updates Last week saw several key legislative hearings.

Patient-Centered 52

Patient-Centered Telehealth Management Finance 52

FDA Law Blog

APRIL 7, 2025

Karst will speak at a session, titled Hitting the Books: Examining Orange and Purple Book Delisting from a Patent Prosecutorial Perspective, along with co-presenters Kim Braslow (Senior Director, IP and Government Affairs, AstraZeneca) and Nicole Woods (Associate Vice President, Assistant General Patent Counsel, Eli Lilly and Company).

Government 59

Government Specialization 59

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. I currently serve as Vice Chair of the Board of the Everylife Foundation. Last Wednesday, the White House hosted its first ever rare disease event.

Government 69

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.

Private Practice 59

Private Practice Government Individual Specialization 59

Georgetown Pediatrics & Family Medicine

MAY 11, 2022

I heard the government will be importing baby formula from other countries. If your child is older than 6 months of age and is usually on regular formula (not a specialty product for allergies or other special health needs), this may be an option. To find an accredited milk bank, check here. Is that safe?

Supply Chain 52

Supply Chain Specialization IT Family Medicine 52

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.

Family Physician 52

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?

Government 69

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.

Manufacturing 52

Manufacturing Government Specialization IT 52

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 Finance 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 91

Management Patient-Centered Finance Transportation 91

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).

Manufacturing 71

Manufacturing Management Specialization Provider 71

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

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’m not sure why. I have been carried through some dark times by humor.

Referral 52

Referral Community Patients Specialization 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 71

Patient-Centered Mental Health Management Finance 71

FDA Law Blog

MARCH 6, 2024

We can offer our readers a special discount for the event. The discount code is S10-896-896L24.S. Details on the conference can be found here.

Management 59

Management Manufacturing Government Specialization 59

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

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Referral Relationship Government Healthcare 59

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.”

Clinic 64

Clinic Clinical Practice Provider Utilities 64

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.

Private Practice 52

Private Practice Government Specialization Management 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. SuperValu is undoubtedly a victory for whistleblowers, and a shot over the bow for recipients of government reimbursements. What was SuperValu all about?

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Government Patient-Centered IT Manufacturing 40

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 Government Specialization IT 52

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 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 Manufacturing Provider Government 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

Board-Certified 52

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.

Management 52

Management Manufacturing Specialization IT 52

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 Supreme Court has sought the views of the Department of Justice on this issue.

Insurance 40

Insurance Manufacturing Government Specialization 40

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.

Management 40

Management Manufacturing Specialization IT 40

Permanente Medicine

MAY 20, 2025

I know for a fact that the government or legislators looked to us in Permanente. So pointing people in the right direction sounds like an easy task, but it’s actually very hard as we begin to really segment our services and get real specialized in what we do. And then putting that on steroids with AI.

Patient-Centered 52

Patient-Centered Patients IT Medical 52

GeriPal

JULY 19, 2024

I don’t have access to change the levers of government. What I know is required, and I think this may be a national requirement for the D SNP beneficiaries, for people in those programs, those people who are a D SNP enrollee, dual special needs plans, which are Medicare, Medicaid. Ana chodos, what should I be? But I don’t.

Screening 119

Screening Primary Care Patient-Centered IT 119

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. Odelia Cooper, MD, Past-President of APDEM, asked how endocrinology fellowship programs can better prepare their graduates for board certification.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

ABIM

JUNE 11, 2025

Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

Board-Certified 52

Board-Certified Government Community Education 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. Community Practice in ABIM Governance* Erica N. Upgrades to the ABIM website and Physician Portal for 2025 designed to make it easier to find information for both physicians and the public.

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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

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.”

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Community Asthma Engineering Complication 52

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

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 55

Management Patient-Centered Physicals Finance 55

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