The Clinical Problem Solvers

JULY 25, 2019

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Specialization 52

Specialization Illness Clinic 52

FDA Law Blog

SEPTEMBER 30, 2022

These remarks by Dr. Dunn and his Summary Review offer insights into the practical application of the FDA’s December 2019 draft guidance on substantial evidence of effectiveness (as we will discuss further below). Hyman, Phelps & McNamara, P.C.’s We would like to acknowledge FDA for its efforts on this devastating condition, ALS.

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Community Provider Patients Specialization 98

PEMBlog

MAY 17, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. Pediatr Radiol 2019; 49:240. 2019 Mar;20(2):409-418. 2019 Mar;20(2):409-418. Epub 2019 Feb 19. 2019 May;20(3):537. 2019 Jul;20(4):688-689. West J Emerg Med. doi: 10.5811/westjem.2019.1.41344.

Patient-Centered 68

Patient-Centered Mental Health Management Finance 68

PEMBlog

JUNE 14, 2023

Special thanks to Manpreet Singh, MD ( @MprizzleER ) for helping to put this collaboration together. 2019 Jul 22;20(5):690-695. These articles will take another look at the content included in this episode. Pediatrics March 2023; 151 (3): e2022057383. 10.1542/peds.2022-057383 West J Emerg Med. doi: 10.5811/westjem.2019.6.42422.

Mental Health 98

Mental Health Management Patient-Centered Finance 98

The Clinical Problem Solvers

OCTOBER 18, 2022

2019 Sep 4;2(9):e1910465. 2019 May;143(5): PMID: 29987170. Association of Childhood History of Parental Incarceration and Juvenile Justice Involvement With Mental Health in Early Adulthood. JAMA Netw Open. doi: 10.1001/jamanetworkopen.2019.10465. 2019.10465. PMID: 31483468. Pediatrics. 2018 Sep;142(3):e20174314. doi: 10.1542/peds.2017-4314.

Healthcare Professional 52

Healthcare Professional Healthcare Patient-Centered Mental Health 52

FDA Law Blog

OCTOBER 2, 2024

We find it surprising that a PCCP may not be submitted with a Special 510(k), given a Special 510(k) may be used to modify an existing device where well-established methods are available to evaluate the change. FDA, Guidance for Industry, The Special 510(k) Program (2019).

Medical 59

Medical Specialization Manufacturing IT 59

FDA Law Blog

JULY 19, 2022

On the other hand, labels that bear so-called “special statements and claims” must be submitted to and approved by FSIS’s Labeling Program and Delivery Staff before they can be used on meat or poultry products. The list of special statements and claims, in FSIS regulation 9 CFR 412.1 (e), e), includes so called “animal raising claims.”

Specialization 52

Specialization IT Provider 52

FDA Law Blog

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. If enacted, Article 5, Section 6 of HF33 would provide for a reduction to the State’s opiate product registration fee.

Hospital 52

Hospital Manufacturing Specialization Medical 52

The Clinical Problem Solvers

DECEMBER 16, 2020

Use of Risk Assessment Tools to Guide Decision-Making in the Primary Prevention of Atherosclerotic Cardiovascular Disease: A Special Report From the American Heart Association and American College of Cardiology [published correction appears in J Am Coll Cardiol. 2019 Jun 25;73(24):3234]. J Am Coll Cardiol. 2019;73(24):3153-3167.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

MAY 8, 2023

Although FDORA gave FDA express authority to allow PCCP , FDA had already been considering creating a mechanism for manufactrurers to prespecify modifications for AI/ML-based software subject to 510(k) premarket notification and de novo classification for several years.

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Manufacturing Provider Medical IT 98

FDA Law Blog

JUNE 23, 2021

For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. Over the years, this function expanded to cancer (renamed the Office of AIDS and Special Health Issues) and, ultimately, all serious and life-threatening diseases (dropping the AIDS nomenclature). By Asking Them.

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

JUNE 22, 2022

In one case, between 2017 and 2019, a Sovah pharmacy technician diverted more than 11,000 schedule II drugs and 1,900 schedule III and IV drugs by indicating in the computer system that they were moved to a location no longer used by the hospital and she destroyed required drug movement forms.

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law Blog

JULY 10, 2023

Understanding the Traditional 510(k) Review Timeline There are three types of Premarket Notification 510(k)s: Traditional , Special , and Abbreviated. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Average Number of Industry Days to MDUFA IV Decision 54.69

Provider 75

Provider IT Engineering Medical 75

GeriPal

NOVEMBER 9, 2023

The initial RCT published on physician coaching in JAMA in 2019 showing that coaching improves quality of life. Eric: … the acknowledgement more, do you want to specialize in geriatrics and be that your focus, or do you want to just have really good skills- Greg: Yes, absolutely. I never did fellowship. Greg: Yeah. .”

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Board-Certified IT Primary Care Referral 110

Annals of Family Medicine

NOVEMBER 20, 2024

This specialized workforce has not yet been classified in health administrative data, limiting our understanding of their individual and medical practice characteristics. Study design and setting: Retrospective cohort study using multiple population-based health administrative datasets in Ontario, Canada in 2019.

Family Physician 130

Family Physician Family Families Primary Care 130

The Clinical Problem Solvers

APRIL 5, 2022

During this episode, we gained insight from special guests Dr. Margot Kushel and Mr. Bobby Watts about what brought them into their fields, how their work reaches the most marginalized, and what can be done at the community and structural level to address homelessness. Published April 5, 2019. January 18, 2019. Rothstein, R.

Community 52

Community Patient-Centered Emergency Room Medical 52

The Clinical Problem Solvers

FEBRUARY 8, 2023

There is a special emphasis on the use of public health models that prioritize harm reduction and person-centered care to prevent drug-related fatalities and curb the opioid epidemic along lines of race and class. Published September 2019. Racial/Ethnic and Geographic Trends in Combined Stimulant/Opioid Overdoses, 2007–2019.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

FDA Law Blog

JUNE 10, 2024

The hospital also “entered into a Memorandum of Agreement with the DEA requiring Palomar Health to undertake additional measures to increase security, implement specialized training, and to handle controlled substances properly and safely.” Palomar Health self-disclosed to DEA that one of its employees may have diverted the fentanyl.

Management 59

Management Patient-Centered Hospital Healthcare 59

Physician's Weekly

JUNE 19, 2025

Bob’s journey here begins in 2019 — the first day of high school for his daughter, Mary. Like I’m having to go outside of that in order to get them the medications that are nothing special. Claire: By the way, Bob asked us just to use his first name for privacy reasons. Dan: Yeah, fair.

Insurance 52

Insurance IT Board-Certified Medical 52

GeriPal

AUGUST 25, 2022

Eric: Alex, we have a super special today. We’ve got a hospice super special. Alex: We have a hospice super special day. Eric: We have a smorgasbord, if you will, of papers that got published recently around hospice, and that’s why we’re calling it a hospice super special. -@AlexSmithMD. Transcript.

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Family Families IT Patients 106

GeriPal

MAY 8, 2025

Summary Transcript CME Summary Weve covered psychedelics on the podcast beforefirst in 2019 with Ira Byock, where we explored their potential role in medicine , and then again in 2023 with Stacy Fischer, Brian Anderson, and Theora Cimino, focusing on the reasons to approach psychedelic use in patients with caution. James 01:34 Yeah, right on.

Illness 107

Illness IT Patient-Centered Patients 107

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

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Referral 40

Referral DO Family Medicine Primary Care 40

GeriPal

MARCH 24, 2023

It’s going to be published as a special report in JPM I hope in May with as of today, 279, I think HPM physician colleagues, signatures including 21 of the living past presidents of the academy. There’s been some great studies that looked at cost, but this study actually looked at cost up to a year before death.

IT 114

IT Provider Patients Family 114

GeriPal

DECEMBER 5, 2024

So has a special resonance for, I think, a lot of people who are Tragically H ip fans. It was late on a Friday afternoon in December 2019. It was my first concert without my parents. And actually this song was the last song they played live ever after, you know, before their lead singer, Gord Down ie , unfortunately died of a gbm.

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IT Community Patients Family 107

FDA Law Blog

JUNE 10, 2025

DEA publishes the Special Surveillance List to inform about potential illicit uses of a laboratory supply and reminds that civil penalties may be imposed on businesses that distribute a laboratory supply with reckless disregard for the illegal uses to which it will be put. DEA published the original Special Surveillance in May 1999.

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Specialization Manufacturing Electronics PCP 69

GeriPal

APRIL 26, 2024

We started writing this paper in 2019 actually. Some numbers to back it up: ELNEC has trained more than 48,000 providers in a train the trainer model Over 1.5 Bry, before we talk about what you did in the paper, let’s take a step back. Why did you decide to write this paper? Bry: Yeah, Eric. It’s funny.

Patient-Centered 119

Patient-Centered IT Patients Consulting 119

Physician's Weekly

JUNE 12, 2025

From 2017 to 2019, during Trump’s first term, Blase served as Trump’s special assistant for economic policy. Before that, he served as a health policy analyst for the Senate Republican Policy Committee and has worked for the Heritage Foundation, a conservative think tank.

Government 52

Government Provider Insurance IT 52

FDA Law Blog

MAY 13, 2025

In examining imported drugs sent through the mail, FDA has identified unapproved drugs, counterfeit drugs, improperly labeled drugs, drugs that failed to meet special storage conditions, and drugs that require supervision of a practitioner licensed by law to administer them. See Proposed Rule, Importation of Prescription Drugs , 84 Fed.

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Manufacturing IT Individual Provider 59