The Clinical Problem Solvers

MARCH 14, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

Mental Health Community Patient-Centered Hospital 52

FDA Law Blog

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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Physician's Weekly

JUNE 24, 2025

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

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Vaccination Illness Hospital Patient-Centered 52

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. Since then, the concept has become a reality.

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The Clinical Problem Solvers

APRIL 24, 2025

Dr. Benton mentors clinical and research physicians, fellows, and postdoctoral trainees. Clinically, he cares for youth and families through the Department of Psychiatry & Behavioral Sciences and the new Division of Addiction Medicine at Boston Children’s Hospital. Child and Adolescent Psychiatric Clinics of North America.

Mental Health 52

Mental Health Community Hospital Appointment 52

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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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Clinic Medical Provider Patients 52

FDA Law Blog

JANUARY 15, 2024

If you made it through the first 2 pages of the opinion, this Court’s answer is clear: FDA flagrantly violated the APA in denying those flavored e-cigarette applications due to the Agency’s utter failure to provide comprehensible instructions and consistent policies. FDA also directed manufacturers to produce detailed marketing plans.

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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?

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Clinic Manufacturing Patients IT 52

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 ). use in education, construction, art, and jewelry).

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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. Providing opportunities to learn new skills and advance their careers not only enhances job satisfaction but also improves the patient experience.<br

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FDA Law Blog

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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Clinic IT Provider Patient-Centered 59

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 ). use in education, construction, art, and jewelry).

Medical 75

Medical Manufacturing Healthcare Government 75

FDA Law Blog

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. The notice was given to Acceleron Pharma, Inc., National Library of Medicine. 42 U.S.C. §

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Clinic Patient-Centered IT Provider 52

FDA Law Blog

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. FDA’s position is, however, only one side of the story.

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Manufacturing Hospital Healthcare Medical 81

FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

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IT Clinic Provider Medical 52

FDA Law Blog

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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Patients Patient-Centered Clinic IT 52

FDA Law Blog

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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Electronics Medical Management Clinic 40

FDA Law Blog

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. The notice was given to Acceleron Pharma, Inc., National Library of Medicine.

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Clinic Patient-Centered IT Provider 40

FDA Law Blog

FEBRUARY 22, 2023

The generation of HF data is a detailed and fairly burdensome process, although certainly short of a full-blown clinical study. FDA says the primary purpose of this draft guidance is to smooth 510(k) reviews by providing more granular information about how to address the requirement. By Jeffrey K. In one way, this is good news.

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Manufacturing Engineering Medical IT 64

CDOCS

MARCH 31, 2021

& Below, a breakdown is provided for the number of appointments needed in the analog workflow (three appointments) compared to the digital CEREC Primescan iJIG workflow (one appointment).& Take clinical photos (7)<br /> 4. Send materials to the lab with clinical photos.</span></p>

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FDA Law Blog

FEBRUARY 26, 2024

FDA provided detailed support, going through almost every instance that Boehringer cites as evidence that FDA interpreted “strength” differently in 2009, to show that FDA has consistently applied the same definition of “strength” since the enactment of the Hatch-Waxman Act. FDA borrowed this definition from 21 C.F.R.

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IT Provider Clinic Medical 59

FDA Law Blog

APRIL 30, 2021

This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data. Unfortunately, FDA has not responded to many suitability petitions filed over the last seven years – preventing submission of ANDAs for drugs in shortage and drugs without generic competition.

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IT Clinic Government Provider 40

FDA Law Blog

APRIL 30, 2021

This bill repeals the requirement to file a suitability petition for ANDAs that do not require clinical data. Unfortunately, FDA has not responded to many suitability petitions filed over the last seven years – preventing submission of ANDAs for drugs in shortage and drugs without generic competition.

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IT Clinic Government Provider 40

Annals of Family Medicine

NOVEMBER 20, 2024

Objective: Identify patient, provider, and healthcare process and utilization factors associated with rates of secondary acceptance of the HPV vaccine. Existing research on secondary acceptance has focused on demographics and initial declination with little evidence around factors associated with increased rates of secondary acceptance.

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FDA Law Blog

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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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. Remember that more deeply understanding your patients can provide meaning! The Clinical Problem Solvers Podcast. Insufficient language services (i.e., January 19, 2021. link] Hampton, F.

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Community Patient-Centered Relationship Healthcare 52

FDA Law Blog

FEBRUARY 5, 2024

Livornese — Last week FDA issued a new draft guidance titled Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. Instead, the information should be self-reported or, if that is not possible, provided by a first-degree relative or knowledgeable representative.

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Clinic Medical Provider Management 59

FDA Law Blog

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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Clinic IT Private Practice Utilities 98

FDA Law Blog

NOVEMBER 29, 2022

Houck — On November 4th, CDC issued its revised guideline on prescribing opioids for pain as an expansion and update of its 2016 CDC Opioid Prescribing Guideline. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. Expected clinical benefits should be weighed against risks before beginning therapy.

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Patients Patient-Centered ER Individual 52

Physician's Weekly

JUNE 11, 2025

Despite the emphasis on U=U as a key HIV prevention strategy since 2016, none of the included studies explicitly described U=U or U=U messaging as an intervention component,” the researchers wrote. This message should be incorporated into counseling during routine clinic visits, especially for people recently diagnosed with HIV.

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Mental Health Healthcare Professional Community Healthcare 114

FDA Law Blog

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

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Medical Physicals IT Healthcare Professional 69

GeriPal

FEBRUARY 15, 2024

The insight started when Carmen, an orthopedic surgeon-researcher, and Katie, a physical therapist- researcher participated in ride-alongs with EMS providers to patient’s homes. And yet, after assisting the older adult to their feet, the EMS providers would leave. I think, as providers, we don’t get to see that.

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Community Transportation IT PCP 115

BMJ

FEBRUARY 8, 2021

The proximity to campus health clinics may also afford college students greater accessibility to healthcare providers for prescription medications such as stimulants which could end up being misused. For healthcare providers, there should be a recognition that holistic care involves more than just prescribing medications.

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Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

DECEMBER 8, 2022

And which of those experiences would you like to share with us that we could then write into a story that we’ll share with providers? It started here at Madison at one and it’s also spread outside the VA now to hospitals in Boston, Providence and now starting up actually in California and UCLA and UCSF. Heather: Yeah.

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The Clinical Problem Solvers

MAY 30, 2022

As healthcare providers, we must listen to our patients and use the power of our presence to see birthing people’s full humanity and empowerment. This policy reflects a societal belief that humans are not valuable unless they provide a service. Published April 20, 2016. Healthcare. 2020;8(1):100367. doi: 10.1016/j.hjdsi.2019.100367

Community 52

Community Patient-Centered Family Families 52

FDA Law Blog

MAY 5, 2024

FDA/HHS Analysis, 2023 FDA/HHS last conducted an eight-factor analysis of marijuana in 2016 and concluded that marijuana continued to meet schedule I criteria. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. 53,688 (Aug.

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Medical Manufacturing Physicals Healthcare Professional 95

GeriPal

APRIL 14, 2022

Adapting Palliative Care Skills to Provide Substance Use Disorder Treatment to Patients With Serious Illness . 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. Right, Katie?

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Illness Patient-Centered IT Patients 102