Clinic, Individual, Manufacturing and Presentation

Researchers Propose Solutions to Improve GLP-1 RA Access

Physician's Weekly

JUNE 18, 2025

Cost-sharing and education may improve access to GLP-1 therapies for obesity, but systemic barriers remain, requiring broader policy and clinical reforms. Other Persistent Barriers & Potential Solutions In another article not presented at the meeting, Stephanie W. They published their insights in Nature Medicine.

Healthcare Professional

Healthcare Professional Insurance Manufacturing Healthcare

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law Blog

OCTOBER 14, 2024

The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. Stem Cell Clinic, LLC , 998 F.3d Regenerative Sciences, LLC , 741 F.3d

Clinic

Clinic Patient-Centered Asthma Patients

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law Blog

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

Manufacturing

Manufacturing Provider Medical IT

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

FEBRUARY 28, 2022

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

Patients

Patients Clinic Medical Patient-Centered

Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

FDA Law Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? It looks similar to the type of procedural informed consent a surgeon ordinarily would present to a patient. The approved devices already have patient‑directed labeling that FDA has approved. What is going on here?

Manufacturing

Manufacturing Provider Patients IT

Urinary Incontinence Revisited: George Kuchel & Alison Huang

GeriPal

JUNE 20, 2024

George 03:01 So I would say that as many clinical issues in older adults, we need to think about them in two ways. Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. Biological aging or physiological aging varies from individual to individual.

IT

IT Patient-Centered Patients Clinic

Case Study: Six single-unit anterior crowns featuring KATANA™ multilayered Zirconia material

CDOCS

JUNE 30, 2021

Furthermore, upon clinical examination and evaluation of radiographs, a diagnosis of recurrent decay was established on teeth #s 6 through 11. [image:Picture1.jpg]<br

Family

Family Families Patients Manufacturing

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

FDA Law Blog

SEPTEMBER 27, 2023

The biggest changes are the addition of Type D and Initial Targeted Engagement for Regulatory Advice on CDER and CBER ProducTs (INTERACT) meetings to the four types already present (Types A, B, B (end of phase), and C), and the addition of additional meeting formats.

IT

IT Manufacturing Provider Clinic

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

SEPTEMBER 20, 2021

As such, we present these programs and initiatives roughly in order of the newest and most substantial changes to more minor. The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries.

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

FDA Law Blog

MAY 19, 2023

Final Release Criteria Special Controls Sponsors will need to provide the final manufacturing release criterion with evidence that lots released at the extremes of the specification will still meet the claimed device performance (i.e., analytical, clinical and stability).

Specialization

Specialization Clinic Provider IT

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing

Manufacturing Provider Physicals Electronics

Will We Ever Have Widespread OTC COVID Testing in America?

FDA Law Blog

FEBRUARY 22, 2022

The good news is that the NIH’s program is real and has been offering helpful assistance to manufacturers seeking to obtain Emergency Use Authorization (EUA) approval from FDA for OTC rapid antigen tests. The NIH screens manufacturers to ensure they have reputable tests already in use in other countries with good supporting test data.

Manufacturing

Manufacturing Screening Provider Clinic

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law Blog

OCTOBER 17, 2023

If you are developing such products, now may be the time to explore the opportunities presented by the Breakthrough Devices Program. In addition, criterion one can also apply to technologies and device features aimed at improving accessibility, defined as “an individual or group’s capacity to benefit from a medical device or procedure.”

Medical

Medical Diagnosis Healthcare Clinic

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

We’ll discuss three recent clinical trials involving patients with serious illness, joined by our guests James Downar , Ali John Zarrabi , and Margaret Ross. Alex 00:33 Our next guest is Margaret Ross, who’s a clinical psychologist and researcher at St. Dr. James, welcome to the GeriPal Podcast. James 00:32 Good afternoon.

Illness

Illness IT Patient-Centered Patients

Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

GeriPal

MARCH 24, 2022

Although, certainly when you start facing complications of serious illness, it is increasingly important to engage as individuals and conversations about goals, values, and preferences. First of all, this does feel primarily like a manufactured controversy. I think Bob also noted documenting it. Eric: Susan. Susan: Yeah.

Illness

Illness IT Healthcare Patient-Centered

A Review of H5N1

Alabama Academy of Family Physicians

FEBRUARY 20, 2025

There have been a few severe cases and one individual died with H5N1 infection. This influenza infection primarily presents in cattle as decreased milk production, lethargy, and decreased appetite. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed.

Patient-Centered

Patient-Centered Provider Manufacturing Screening

Primary Care Digest

Researchers Propose Solutions to Improve GLP-1 RA Access

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

Trending Sources

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

Urinary Incontinence Revisited: George Kuchel & Alison Huang

Case Study: Six single-unit anterior crowns featuring KATANA™ multilayered Zirconia material

FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

Less than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight

Will We Ever Have Widespread OTC COVID Testing in America?

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

Advance Care Planning Discussion: Susan Hickman, Sean Morrison, Rebecca Sudore, and Bob Arnold

A Review of H5N1

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