FDA Law Blog

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

Clinical Practice 88

Clinical Practice Clinic Government Management 88

Annals of Family Medicine

NOVEMBER 20, 2024

Context: Adults with complex needs require health and social services from a variety of providers, which can lead to frequent use of services. Setting: Two health and social services organizations and 5 primary care clinics in Quebec, Canada. Case B: 12 operational committee meetings; 8 clinical support meetings; 14 people trained.

Integrated Care 130

Integrated Care Primary Care Healthcare Professional Management 130

The Direct Doctors Difference

AUGUST 18, 2021

According to DPC Frontier, a site owned by a DPC physician/lawyer who was a founder of the movement, there are now over 1500 clinics doing pure Direct Care across the nation. Clinics are often owned by solo doctors or, as in the case of Direct Doctors, by 2-3 physicians in a small group practice.

Primary Care 52

Primary Care Healthcare Insurance Government 52

Permanente Medicine

APRIL 16, 2025

NWP and TPMG are physician-led, independent Permanente Medical Groups who partner exclusively with Kaiser Foundation Health Plan to provide care for their patients in Oregon, southwest Washington, and Northern California. By collaborating clinically, sharing innovations, and supporting physicians and staff, NWP will improve quality of care.

Medical 52

Medical Patient-Centered Community Hospital 52

Annals of Family Medicine

NOVEMBER 20, 2024

Vaccine hesitancy is higher among rural Americans for many reasons including perceptions of risk of COVID-19, personal and/or religious reservations about the vaccines, distrust of the government and misinformation about the COVID-19 vaccinations.

Vaccination 130

Vaccination Primary Care Patient-Centered Community 130

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.

Healthcare 130

Healthcare Family Physician Management Individual 130

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.,

Appointment 52

Appointment Board-Certified Patient-Centered Integrated Care 52

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.

Healthcare Professional 52

Healthcare Professional Healthcare Community Medical Advice 52

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.

Patient-Centered 40

Patient-Centered Clinic Provider Patients 40

Physician's Weekly

JUNE 26, 2025

When a child has risk factors but has not developed the disease, we must continue to provide preventive care and support for the family and appropriately match intensity and dose of the intervention. What modifications would you recommend to clinicians? This starts with recognition that obesity is a chronic disease.

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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.

Healthcare 52

Healthcare Healthcare Professional Consulting Management 52

PEMBlog

JUNE 7, 2023

There are protocols in place that assist highly trained Emergency Medical Service providers in assuring that agitated children are safely transported to their destination. Government. NASEMSO: Clinical care and restraint of agitated or combative patients by emergency medical service practitioners.

Transportation 122

Transportation Patient-Centered Management Finance 122

Common Sense Family Doctor

MARCH 18, 2025

The COVID-19 pandemic and the isolation caused by public health measures to slow its spread exacerbated a mismatch between the need for mental health care and the number of professionals trained to provide that care. Even though stigma prevents many persons with mental health problems from seeking care, there has never been enough go around.

Mental Health 52

Mental Health IT Primary Care Primary Care Physician 52

Physician's Weekly

JUNE 24, 2025

Deana Hendrickson, 66, who provides daily care for three young grandsons in Los Angeles, sought an additional MMR shot, though she was vaccinated against measles, mumps, and rubella as a child, in case her immunity to measles had waned. “I’m sort of hectoring,” she acknowledged. The nation’s health secretary, Robert F.

Vaccination 52

Vaccination Illness Hospital Patient-Centered 52

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. .

Clinic 52

Clinic Provider IT Patients 52

ABIM

APRIL 24, 2025

Dave, MD, MPH , inquired how stressors may contribute to candidates failing the certification examination and Dr. McDonald stated that knowledge gaps were the primary cause, though ABIM provides safeguards to reduce stress like grace periods and consideration of compassionate exemptions for extraordinary life circumstances.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

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-labeled reagents and materials are often used in LDTs in clinical laboratories. By Steven J.

IT 64

IT Manufacturing Government Clinic 64

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.

Clinic 52

Clinic Medical Provider Patients 52

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. By David B. Clissold & Sara W.

Manufacturing 115

Manufacturing IT Provider ER 115

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

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. an intermediate clinical endpoint) and that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

Clinic 64

Clinic Relationship Provider IT 64

The Clinical Problem Solvers

NOVEMBER 22, 2021

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. The Clinical Problem Solvers Podcast. This flawed measure can be harmful for many reasons. November 23, 2021. TRANSCRIPT

Community 52

Community Patient-Centered Medical Student Medical 52

FDA Law Blog

JULY 8, 2024

The Seventh amendment provides that in “suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise reexamined in any court of the United States.” So the SEC has the option of retrying Jarkesy in a district court.

Government 59

Government IT Provider Clinic 59

Permanente Medicine

MAY 20, 2025

” “Whether you’re the call center agent, the receptionist, [or] the lab tech, you participate and you provide the input into innovation,” said Dr. Nguyen. The Southern California Permanente Medical Group is one of the largest medical groups in the nation with more than 8,800 physicians providing care for over 4.8

Patient-Centered 52

Patient-Centered Patients IT Medical 52

FDA Law Blog

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. 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.

Medical 98

Medical Manufacturing Healthcare Government 98

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). Javitt & Allyson B.

Clinic 59

Clinic Management Medical IT 59

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]. What can we do to solve this problem?

Patient-Centered 52

Patient-Centered Government Referral Hospital 52

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. There has to be effective support provided behind any type of screening strategy in order for it to truly be effective.

Screening 120

Screening Primary Care Patient-Centered IT 120

FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

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. §

Clinic 64

Clinic IT Utilities Government 64

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. Inconsistency in care delivery So as every provider shapes her practice around MyChart, each will do it in a slightly different way.

Patients 75

Patients IT Provider Family Doctor 75

FDA Law Blog

SEPTEMBER 6, 2022

As the new Federal Register notice explains, FDA issued the 2016 Guidance in question and answer format to respond to the most frequently asked questions about charging for investigational drugs provided under an IND for either clinical trials or expanded access for treatment use under 21 CFR section 312.8. Not all that much.

Clinic 52

Clinic Manufacturing Patients IT 52

FDA Law Blog

MARCH 1, 2023

The report recommends using a QMM rating that is shared throughout the market (purchasers, consumers, competing manufacturers) to provide manufacturers committed to QMM with a competitive advantage. On November 2, 2022, the FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee held a meeting on CDER’s QMM Program.

Management 45

Management Manufacturing Supply Chain Provider 45

FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law Blog

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA.

Government 40

Government Clinic Individual Provider 40

FDA Law Blog

JANUARY 18, 2022

The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. 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.

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added). 18 U.S.C. § 220(b)(2).

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Lab Testing Referral Individual Patient-Centered 52