FDA Law

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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Manufacturing IT Provider ER 115

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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Provider Medical Manufacturing Consulting 59

FDA Law

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. Koblitz & Kurt R. FDA borrowed this definition from 21 C.F.R.

IT 59

IT Provider Clinic Medical 59

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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

Clinic 52

Clinic Medical Provider Patients 52

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In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ).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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Medical Manufacturing Healthcare Government 98

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This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance).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 The Draft Guidance covers charging in a clinical trial or in one of the expanded access settings and the differences between them. What’s new in the new Draft Guidance?

Clinic 52

Clinic Manufacturing Patients IT 52

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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Manufacturing Hospital Healthcare Medical 81

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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Board-Certified Education Specialization Clinic 40

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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Clinic IT Provider Patient-Centered 59

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.

Medical 75

Medical Manufacturing Healthcare Government 75

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. §

Clinic 52

Clinic Patient-Centered IT Provider 52

FDA Law

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.

IT 52

IT Clinic Provider Medical 52

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.

Patients 52

Patients Patient-Centered Clinic Community 52

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.

Manufacturing 64

Manufacturing Engineering Medical IT 64

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.

Electronics 40

Electronics Medical Management Clinic 40

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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Appointment Family Families Patients 52

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. §

Clinic 40

Clinic Patient-Centered IT 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

IT 40

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

IT 40

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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Patient-Centered Clinical Practice Patients Individual 75

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!)

IT 106

IT Patient-Centered Healthcare Illness 106

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! Insufficient language services (i.e., provision in only English +/- Spanish), limitations of medical technology (i.e.,

Community 52

Community Patient-Centered Relationship Healthcare 52

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. Going into patient’s homes was eye opening. Their job was done.

Community 116

Community Transportation IT PCP 116

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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Clinic IT Private Practice Utilities 98

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

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. So here we go.

Illness 103

Illness Patient-Centered IT Patients 103

FDA Law

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.

Clinic 59

Clinic Medical Provider Management 59

GeriPal

DECEMBER 8, 2022

Summary Transcript Summary. Eric and I weren’t sure what to call this podcast – storytelling and medicine? Narrative medicine? We discussed it with today’s guests Heather Coats, palliative care NP-scientist, and Thor Ringler, poet. It wasn’t until the end that the best term emerged – storycatching. It’s since spread to over 70 VAs.

Patient-Centered 116

Patient-Centered Illness Healthcare IT 116

FDA Law

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.

Patients 52

Patients Patient-Centered ER Individual 52

GeriPal

FEBRUARY 29, 2024

Accreditation In support of improving patient care, UCSF Office of CME is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team. Lynn: Okay.

IT 127

IT Patient-Centered Illness Education 127

FDA Law

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.

Medical 69

Medical Physicals IT Healthcare Professional 69

GeriPal

MARCH 28, 2024

Ten years ago we would have been hard pressed to find 3 clinical trial abstracts submitted to the annual meeting, much less high quality randomized trials with robust measures, sample sizes, and analytics plans. I’m just stunned even writing that! We’ve come so far as a field. This is Eric Widera. Alex: This is Alex Smith. Eric: Nudge it.

Consulting 116

Consulting Patient-Centered IT Patients 116

GeriPal

APRIL 10, 2025

Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it. Alex 00:31 And we’re delighted to welcome Fernanda Bellolio, who is an emergency medicine physician and professor of emergency medicine at the Mayo Clinic. They got feedback.

Patient-Centered 78

Patient-Centered IT Hospital Patients 78

GeriPal

APRIL 3, 2025

We used all of our political capital to make sure it happens in Chicago, which is where we started for the literature Updates back in 2016, back when it was just me and Ken, and then we brought in Alex, like two years later. Annie 05:16 So if you look back in history, I think Eric and Ken have been doing this since 2016. Of course.

IT 65

IT Hospital Screening Patients 65

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.

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

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. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

Illness 144

Illness IT Medical Provider 144

FDA Law

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. 29, 2023). Letter to U.S. and lack accepted safety for use under medical supervision.

Medical 95

Medical Manufacturing Physicals Healthcare Professional 95