FDA Law Blog

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. RUO certification programs were something that FDA had, at one time, recommended.

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California Academy of Family Physicians (CAFP)

MAY 14, 2025

Key Health Care Budget Proposals: Proposed Medi-Cal Cuts and Enrollment Changes Medi-Cal, California’s Medicaid program, is typically funded through a partnership between the state and the federal government. To fill that gap, California has chosen to use state-only funds to provide certain Medi-Cal benefits to undocumented Californians.

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ABIM

JUNE 12, 2025

He emphasized ABIM’s focus on patient-centered standards and promoting high-quality care, as well as ABIM’s commitment to ensuring a diverse governance that reflects the physician and patient population. 4,372 of these (92%) also have a current valid certificate in Internal Medicine.

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Annals of Family Medicine

NOVEMBER 20, 2024

The model, which involves co-governance between Atikamekw and organizational players, is deployed through three pillars of action at clinical, staff and organizational levels.

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Physician's Weekly

JUNE 26, 2025

The 2023 American Academy of Pediatrics (AAP) Clinical Practice Guidelines has a section that discusses different approaches (eg, virtual visits, including allied providers, thinking about community programs, etc.). We also need to pick up on when a child is gaining weight rapidly or crossing percentiles so we can intervene earlier.

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FDA Law Blog

OCTOBER 1, 2024

District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). Or consider Vanda’s lawsuit filed in the U.S. In January 2024, the U.S.

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My Green Doctor

MAY 3, 2025

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Powering Health, Protecting the Planet – Why Renewable Energy Belongs in Every Clinic Healthcare professionals have always been trusted voices on public health.

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My Green Doctor

APRIL 4, 2025

It tells your office colleagues and patients that your healthcare practice or clinic is committed to forging a healthier work space and community. Behavior Change Happens in the Exam Room Unlike government agencies or corporations, healthcare professionals speak directly to individuals in a trusted, one-on-one setting. of total U.S.

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Permanente Medicine

APRIL 16, 2025

Both groups have a shared mission of delivering high-quality, cost-efficient care that achieves superior clinical outcomes. By collaborating clinically, sharing innovations, and supporting physicians and staff, NWP will improve quality of care. Kaiser Permanente in Northern California received 4.5

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Permanente Medicine

MAY 22, 2025

As chief quality officer at The Permanente Federation, Dr. Bridges oversees coordination of national clinical quality care programs across Kaiser Permanente for its 12.6 Visionary physician leader to oversee national coordinated efforts that support and advance Kaiser Permanente’s acclaimed levels of high-quality care OAKLAND, Calif.,

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Physician's Weekly

JUNE 24, 2025

has long disparaged certain vaccines, calling them unsafe and saying that the government officials who regulate them are compromised and corrupt. Her doctor and several pharmacies turned her down because she was below the recommended age at the time, which was 60. So, in 2016, she celebrated her 60th birthday at her local CVS. Kennedy Jr.,

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BMJ

AUGUST 20, 2021

Donors, government ministries, agencies and academic partners regularly cascade requests for data that multiply and complicate the simple interaction into a complex, and often redundant, set of data requirements for the same singular interaction. Mobile phone penetration has finally exceeded 90% in low- and middle-income countries.

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FDA Law Blog

JULY 24, 2023

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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FDA Law Blog

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements.

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ABIM

APRIL 24, 2025

The questionnaire gathers information about clinical work and practice patterns, and ABIM uses the information to help update exam blueprints, develop policies for initial certification and MOC, and ensure adequately diverse representation of the profession in research. The following is a summary report of the spring meeting.

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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.

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PEMBlog

JUNE 7, 2023

Government. NASEMSO: Clinical care and restraint of agitated or combative patients by emergency medical service practitioners. 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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FDA Law Blog

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. Clissold & Sara W.

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Georgetown Pediatrics & Family Medicine

MAY 11, 2022

They may have samples in stock, connections to other local organizations, or ideas of other places to call, such as your local WIC clinic. 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 social media groups. This should never be done.

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FDA Law Blog

AUGUST 4, 2022

That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability. Pfizer, Inc. Department of Health and Human Services et al. July 25, 2022. Pfizer appealed to the Second Circuit.

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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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FDA Law Blog

OCTOBER 24, 2023

These guidances focused on the types of scientific publications (journal articles, reference texts, and in 2014, clinical practice guidelines) and necessary accompanying information that firms could proactively provide in a manner that would not, on its own, constitute evidence of a new intended use.

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FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance.

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FDA Law Blog

JULY 8, 2024

According to the dissent, where the government is the claimant, it concerns a public right. As the dissent points out, the federal government has operated for decades on the assumption that many disputes can be adjudicated by ALJs. Jarkesy. According to the Court, the remedy is considered the more important factor.

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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). She would peer out at the gate of the clinic and start predicting what cases we would see. So you came to the clinic after you went out to get yourself damaged? I’m not sure why.

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The Clinical Problem Solvers

NOVEMBER 22, 2021

The term “Native American” is frequently used but does not cover Indigenous Peoples from across the world The Burden of Proof Dr. Sequist discusses “blood quantum”, which is an attempt by the federal government to reduce one’s identity as an Indigenous person to a percentage of blood affiliated with specific Tribes in the US. TRANSCRIPT

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FDA Law Blog

JANUARY 12, 2025

Background on Accelerated Approval The key concept, an ingenuity of FDA itself that has been around since the beginning of accelerated approval, is to allow earlier access to a promising therapy for a serious condition with an unmet medical need based on an endpoint that is reasonably likely to predict clinical benefit.

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GeriPal

JULY 19, 2024

Joe 03:55 You know, my thoughts are screening is important for a variety of reasons, and certainly Doctor Boris and Soo and Anna, Doctor chodos can provide a lot greater clinical insight than I. 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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FDA Law Blog

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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FDA Law Blog

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. adequate to justify the proposed clinical testing.” 21 U.S.C. § 355(i)(1)(A). 42 U.S.C. §

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FDA Law Blog

AUGUST 29, 2021

The federal government does its own version of rebranding with each change in administration. clinical testing of implanted brain computer interface devices for patients with paralysis or amputation), enforcement (e.g., Walsh & JP Ellison — Companies often use rebranding to reposition and refocus their business.

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FDA Law Blog

JANUARY 18, 2022

The regulatory requirements for the devices that are 3D-printed generally govern the responsibilities of the entities that are manufacturing and distributing the 3D printing equipment for that use at the point of care. This guidance document is still in effect today. Rather, it is meant to present various scenarios related to use of 3D?printed

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Tiny Physician

FEBRUARY 15, 2022

Incompetent government The doctor-patient ratio of India is one of the worst in the world; we have 1 doctor for 1456 people against the WHO recommendation of 1:1000 [5]. There is only 1 government doctor for a population of 11,000 people and there is only 1 dental surgeon per 175,000 people [6]. are not met.

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33 Charts

OCTOBER 2, 2021

And as suggested recently in the New England Journal of Medicine , One of the most important factors at play in the clinical environment is the apparent tension between availability and attention. Some will convert their practice into a virtual clinic with late night pajama time ‘sessions’ while others will recognize the need for guardrails.

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PEMBlog

JUNE 14, 2023

Government. Characteristics, Clinical Care, and Disposition Barriers for Mental Health Patients Boarding in the Emergency Department. It is also the final episode in a 5 episode series focused on agitation in children and adolescents. PMID: 32393605. American Journal of Emergency Medicine. Doi.org/10.1016/j.ajem.2020.11.021

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FDA Law Blog

OCTOBER 7, 2024

FDA has civil money penalty authority relating to clinical trials, devices, foods, drugs, and tobacco; although with the exception of tobacco, FDA has not recently exercised that authority with regularity. By JP Ellison & Anne K. Walsh — It took only 3 months. Constitution’s Seventh Amendment right to a jury trial. 2117 (2024).

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Tiny Physician

JULY 3, 2022

However, homeopaths have the tendency to make medicines from any substance and no government authority questions them. Kerala Government even gave Arsenic album tablets to school-going children to improve their immunity against COVID, which proved that our awareness about science is next to nil. Yeah, you heard it right, moon.

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