2016, Clinic and Government - Primary Care Digest

Governor’s 2025-26 May Revision Proposes Major Cuts to Healthcare and Undermines Medi-Cal Expansion Commitments

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

Healthcare Family Physician Management Individual

Many Older People Embrace Vaccines. Research Is Proving Them Right.

Physician's Weekly

JUNE 24, 2025

So, in 2016, she celebrated her 60th birthday at her local CVS. 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.

Vaccination

Vaccination Illness Hospital Patient-Centered

Agitation Podcast Series Episode 5: Management of the child with mental health problems who is boarded in the ED

PEMBlog

JUNE 14, 2023

Government. Children’s Mental Health Emergency Department Visits: 2007-2016. Characteristics, Clinical Care, and Disposition Barriers for Mental Health Patients Boarding in the Emergency Department. Pediatrics. 2020 Jun;145(6):e20191536. doi: 10.1542/peds.2019-1536. Epub 2020 May 11. PMID: 32393605.

Mental Health

Mental Health Management Patient-Centered Illness

The Most Engaging Decision You’ll Read All Year – Five Stars

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

Manufacturing IT Provider ER

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Other medical information.

Clinic

Clinic Medical Provider Patients

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

FDA Law Blog

SEPTEMBER 6, 2022

This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. The Draft Guidance covers charging in a clinical trial or in one of the expanded access settings and the differences between them. What’s new in the new Draft Guidance?

Clinic

Clinic Manufacturing Patients IT

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). products intended for medical purposes).

Medical

Medical Manufacturing Healthcare Government

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law Blog

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). products intended for medical purposes).

Medical

Medical Manufacturing Healthcare Government

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

APRIL 30, 2021

Government Accountability Office report here ). This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data. As we perused the bills, we sorted them into three categories: the Good, the Bad, and the Ugly. Modernizing Therapeutic Equivalence Rating Determination Act (S.

IT

IT Clinic Government Provider

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

FDA Law Blog

APRIL 30, 2021

Government Accountability Office report here ). This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data. As we perused the bills, we sorted them into three categories: the Good, the Bad, and the Ugly. Modernizing Therapeutic Equivalence Rating Determination Act (S.

IT

IT Clinic Government Provider

Clinical Research Representation: Pass it On

FDA Law Blog

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. Since 1993, Congress has continued to direct the federal government, and in particular FDA, to take steps to close the gap in clinical research representation.

Clinic

Clinic IT Healthcare Medical

What is going on with MAID in Canada? Bill Gardner, Leonie Herx, & Sonu Gaind

GeriPal

JANUARY 11, 2024

The number of people who have used MAID in Canada since it was legalized in 2016 has increased year on year from about 1,000 people in the first year to over 13,000 people in 2022. Alex: We’re delighted to welcome Leonie Herx, who’s a palliative care physician and clinical professor at the University of Calgary. Eric: Yeah.

Illness

Illness IT Medical Provider

Aging and Homelessness: Margot Kushel

GeriPal

APRIL 20, 2023

I would talk about this, except I was a clinician, and I’m seeing these folks in the hospital and in clinic. The journal section’s requirements are the same as for a clinical investigation. In what moral universe is a federal government deeply subsidizing my housing and not subsidizing that of my patients?

Mental Health

Mental Health IT Community Individual

Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

GeriPal

DECEMBER 21, 2023

And that’s where, based on this, I made a decision to leave University of North Carolina to come to Indiana University because my mentor, Chris Callahan, just received the grant from AHRQ to build the first randomized clinical control trial that evaluated the comprehensive dementia care model. 2015, 2016. Malaz: Yeah.

Patient-Centered

Patient-Centered IT Families Family

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

FDA Law Blog

JUNE 1, 2025

Government Accountability Office (GAO) published a report finding that, for the years 2016-2018, the pharmaceutical industry spent on average for a sample of 553 drug products approximately $6 billion annually on DTC advertisements, with a significant portion of this spending allocated to television commercials. In 2021, the U.S.

Healthcare Professional

Healthcare Professional Manufacturing Healthcare Utilities

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

FDA Law Blog

SEPTEMBER 13, 2021

Currently, individual Medicare Part D plan sponsors negotiate rebates but the government is explicitly prohibited from interfering in those negotiations. The attraction of the repeal is that Part D negotiations can potentially save the federal government “hundreds of billions of dollars,” as explained in the Plan.

Manufacturing

Manufacturing Supply Chain Patient-Centered Utilities

Primary Care Digest

Governor’s 2025-26 May Revision Proposes Major Cuts to Healthcare and Undermines Medi-Cal Expansion Commitments

Many Older People Embrace Vaccines. Research Is Proving Them Right.

Trending Sources

Agitation Podcast Series Episode 5: Management of the child with mental health problems who is boarded in the ED

The Most Engaging Decision You’ll Read All Year – Five Stars

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

Answers to the Most Frequently Asked Questions about the Previous Answers to the Most Frequently Asked Questions about Charging for Investigational Drugs

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

The Good, the Bad and the Ugly: New Legislation Would Reform the ANDA Suitability Petition Process and Require Timely Assignment of 505(b)(2) NDA Therapeutic Equivalence Evaluation Codes (“the Good”)

Clinical Research Representation: Pass it On

What is going on with MAID in Canada? Bill Gardner, Leonie Herx, & Sonu Gaind

Aging and Homelessness: Margot Kushel

Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

Senator Durbin Has Questions About FDA’s “Operational Capacity” to Oversee DTC Prescription Drug Advertising Amid Workforce Reductions – Don’t We All?

Drug Pricing Reform Gathers Steam (Part 1): White House Drug Pricing Plan Offers Laundry List of Existing Democrat Priorities

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