The Medical Futurist

MAY 18, 2025

Clinical use is already accepted, new FDA approvals and new trials are underway targeting new niches, like pediatric surgeries. They have started a large-scale clinical trial involving 10,000 patients, expected to last two years, with plans to obtain CE marking by the end of 2024. But there is undoubtedly impressive progress.

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California Academy of Family Physicians (CAFP)

MAY 14, 2025

Elimination of (State-Only) Prospective Payment System Rates to Federally Qualified Health Centers and Rural Health Clinics for Undocumented Immigrants – Eliminates Prospective Payment System rates to clinics for state-only-funded services provided to undocumented Individuals.

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Plum Health

MAY 11, 2023

Thomas graduated from Wayne State University School of Medicine in 2013 - thereafter, he completed his residence at Oakwood/Beaumont Family Medicine Residency Program, and then started Plum Health DPC in November 2016. Time flies when you’re practicing medicine - the days are long but the years are short.

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Physician's Weekly

JUNE 24, 2025

So, in 2016, she celebrated her 60th birthday at her local CVS. A connection to dementia will require further research, and Geldsetzer is trying to raise philanthropic funding for a clinical trial. Her doctor and several pharmacies turned her down because she was below the recommended age at the time, which was 60.

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FDA Law

FEBRUARY 26, 2024

Koblitz & Kurt R. Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

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FDA Law

JANUARY 15, 2024

In 2016, FDA determined that e-cigarettes and their component parts fell under the term “new tobacco products,” requiring manufacturers of such products to submit PMTAs for FDA review before the Agency would issue a marketing order permitting the legal sale of the product.

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NPR Health

DECEMBER 20, 2024

She's been on dialysis for four hours a day, three days a week since 2016. So the Food and Drug Administration made an exception to its usual clinical study requirements to allow Looney this new kind of pig kidney. Towana is a 53-year-old grandmother from Gadsden, Ala. Her immune system would reject a human kidney.

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FDA Law

JUNE 3, 2025

The assertion that prescribing immediate-release opioids longer than two or three months is a red flag may have originated with the Center for Disease Control and Prevention (CDC) 2022 Clinical Practice Guideline for Prescribing Opioids for Pain. Attorneys Office, Northern District of Illinois, April 21, 2025, quoted here. Recommendation 1.

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PEMBlog

OCTOBER 17, 2023

The diagnosis can be made clinically. Clinical Pediatric Dermatology 5 th ed, Elsevier, 2016, 382-401. The Mayo Clinic Experience With Psychogenic Purpura (Gardner-Diamond Syndrome). This is a viral exanthem caused by Parvovirus B19. It is rare and usually seen in young adults rather than children. Gu SL, Jorizzo JL.

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FDA Law

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

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?

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FDA Law

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 ). This guidance document is still in effect today.

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PEMBlog

JUNE 14, 2023

Children’s Mental Health Emergency Department Visits: 2007-2016. 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. Pediatrics. 2020 Jun;145(6):e20191536.

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FDA Law

NOVEMBER 1, 2023

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.

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CDOCS

MARCH 4, 2024

<p>According to the Dental Assisting National Board, dental assistant job satisfaction has declined every year since 2016, and currently only 50% feel valued by their employer. Within the last year, feeling under appreciated is now the second highest reason dental assistants are leaving the dental field.</p> </p>

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FDA Law

FEBRUARY 29, 2024

A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. That did not happen.

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FDA Law

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. Cato & Michelle L. The notice was given to Acceleron Pharma, Inc., 42 U.S.C. §

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FDA Law

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 ). This guidance document is still in effect today.

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FDA Law

JUNE 29, 2022

It explains that “FDA typically gives greater weight to trials that are conducted in larger populations, use a well-understood and widely accepted, well-constructed clinical endpoint, and incorporate certain design features (e.g., Both documents describe the process in two steps: the intent to rescind step and the rescinding step.

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FDA Law

JUNE 23, 2021

I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.

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FDA Law

NOVEMBER 20, 2024

Since the first issuance of FDA’s guidance Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in 2016, sponsors submitting premarket submissions to FDA have had the option of using these techniques to evaluate certain biocompatibility endpoints.

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FDA Law

FEBRUARY 22, 2023

The generation of HF data is a detailed and fairly burdensome process, although certainly short of a full-blown clinical study. By Jeffrey K. Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. In one way, this is good news.

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FDA Law

MAY 3, 2021

Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The ClinicalTrials.gov database is a public database of clinical studies administered by the U.S. Cato & Michelle L. The notice was given to Acceleron Pharma, Inc., 42 U.S.C. §

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CDOCS

MARCH 31, 2021

Take clinical photos (7)<br /> 4. Send materials to the lab with clinical photos.</span></p> National Director, Clinical Technology Solutions of MicroDental Laboratories. ¹ In total, these 3 appointments could take up to 4 weeks to complete.</span></span></p>

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FDA Law

APRIL 20, 2021

Certain types of clinical decision-support software. Calculator/Data Processing Module for Clinical Use. Remove non-device software functions intended for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results. By McKenzie E. 21 C.F.R.). Device Type. Modification.

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Tiny Physician

AUGUST 12, 2021

The faculties of clinical subjects are not angels either. In the year 2016 Trivandrum Medical College: the most prestigious medical college of Kerala, released a circular which mentioned a dress code for boys and girls. Kerala is known for its 100% literacy and better ranks in almost all social development indices.

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PEMBlog

SEPTEMBER 24, 2024

Most patients are afebrile by the third day of treatment and clinically improved within two weeks. doi: 10.1128/microbiolspec.TNMI7-0032-2016. The CT also showed normal pulmonary venous return via the left lower pulmonary vein. 2018 Jul;48(3):247-250. doi: 10.1177/0049475518765305. Epub 2018 Apr 6. PMID: 29621946. Lyon SM, Rossman MD.

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FDA Law

APRIL 30, 2021

This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data. While we’re pretty excited about the changes both bills would make to the law, we’re particularly stoked about S. 1462, the “Simplifying the Generic Drug Application Process Act.”. Curiously, the most recent version of MaPP 5240.5

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IT Clinic Government Provider 40

FDA Law

APRIL 30, 2021

This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data. While we’re pretty excited about the changes both bills would make to the law, we’re particularly stoked about S. 1462, the “Simplifying the Generic Drug Application Process Act.”. Curiously, the most recent version of MaPP 5240.5

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IT Clinic Government Provider 40

FDA Law

MARCH 17, 2022

We blogged on the final 2016 guideline here on March 17, 2016). Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids, 87 Fed. et al, CDC Clinical Practice Guideline for Prescribing Opioids-United States, 2022, CDC. 2016 Guideline. CDC Clinical Practice Guideline, 10. 7,838 (Feb.

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FDA Law

JUNE 9, 2025

These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care. These events marked a turning point in expanding representation in clinical studies and opening the door to more personalized medical care.

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GeriPal

DECEMBER 15, 2022

Summary Transcript Summary. We’ve talked at length on prior podcasts about the failures of aducnumab, Biogen, and the FDA’s decision to approve it. . But wait, there’s a shiny new anti-amyloid drug, lecanemab! (No No it’s not just the French version of Aducanumab). . In an article in the NEJM (a published article this time, wonder of wonders!)

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GeriPal

OCTOBER 10, 2024

And they begin on today’s podcast with one clinical ask: everyone should be a generalist and a specialist. They are looking to build on both their research and clinical programs and are interviewing candidates for the Associate Chief of Research and for full-time physician faculty to join them in the inpatient and outpatient setting.

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FDA Law

JUNE 7, 2021

However, the FDA guidance goes on to say in some cases, additional context is needed by specifically inserting a sentence in the indications statement that: no clinical benefit has been established. be “reasonably likely to predict” ultimate clinical benefit). be “reasonably likely to predict” ultimate clinical benefit).

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The Clinical Problem Solvers

DECEMBER 20, 2021

Highlight how structural racism against Asian-Americans surfaces in clinical settings, and describe means of counteracting such structures. [link] CPSolvers: Anti-Racism in Medicine Series Episode 13: Centering Asian Americans: Racism, Violence, and Health Show Notes by Naomi F. Insufficient language services (i.e.,

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Physician's Weekly

JUNE 26, 2025

This is the earliest West Nile virus case reported in Illinois since 2016. More information The Cleveland Clinic has more on West Nile virus. THURSDAY, June 26, 2025 (HealthDay News) — Illinois has confirmed its first human case of West Nile virus this year, health officials say. Centers for Disease Control and Prevention (CDC).

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GeriPal

APRIL 14, 2022

So I have thought about this for months, maybe years since your 2016, cycle blog, but we have picked Under Pressure by David Bowie and Queen. This is both a research and a clinical interest of yours. It’s been around for a long time but is acting like the hot new kid in town. But does this drug really live up to the hype? Right, Katie?

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