FDA Law

DECEMBER 4, 2023

Lack of Individual Drug Therapy Pattern prescribing can occur when physicians prescribe the same drugs, in the same quantities, in the same strengths to their patients, or a patient receives the same controlled substances repeatedly with no adjustment or change in therapy. On October 10th, based on ability to pay, the U.S. 21 U.S.C. §

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Treatment Plan ER Government Patient-Centered 139

FDA Law

MAY 13, 2024

FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices. However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice.

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Medical Clinic Patients IT 111

PEMBlog

MAY 1, 2025

Learning Objectives Describe the classic and atypical clinical presentations of Parvovirus B19 infection in pediatric patients, including erythema infectiosum, arthropathy, transient aplastic crisis, and chronic anemia in immunocompromised hosts. So as you can see, this virus does a lot of stuff. But what is it? Well, let’s get nerdy.

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Complication Patient-Centered Patients Clinic 83

FDA Law

JUNE 23, 2021

Valentine — For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. By James E.

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Patients Patient-Centered Clinic Community 52

FDA Law

MAY 19, 2025

86, 72703 (December 22, 2021), DEA emphasized in the Gulf Med decision that prescribing [r]ed flags are circumstances surrounding a prescription that cause a pharmacist to take pause, including signs of diversion or the potential for patient harm. By Larry K. Houck Last month the U.S. As mentioned in Federal Register Vol. 81, 86, 251.

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Individual Patients Provider Medical 64

PEMBlog

OCTOBER 16, 2023

The patient completed the miralax cleanout followed by daily miralax, and started having soft, formed stools daily without any pain (Bristol type 4). Physical exam The patient had stable vital signs and an exam notable for tenderness to palpation over the right lower quadrant and suprapubic region without any peritoneal signs.

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PCP PCP Diagnosis Diagnose 69

PEMBlog

JULY 17, 2023

this is an updated version for July 2023 Replace a G-tube Gastrostomy tube dislodgment and malfunction are top causes for G-tube related ED visits in pediatric patients so it is important to understand how to replace a G-tube. Guage this based on ease of insertion and patient comfort. 8, 2012, pp. Showalter, Cory D.,

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IT Family Families Complication 52

PEMBlog

MAY 11, 2023

Some general recommendations to reduce pain during LP include: Comfortable Positioning: The patient should be instructed to lie on their side with their knees drawn up to their chest and their chin tucked in, or sit upright with their head and upper back forward (often on a bedside table with a pillow). Is there evidence for the J-Tip?

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Patient-Centered Provider IT Patients 52

FDA Law

FEBRUARY 29, 2024

As FDA explains on its website (which includes lists— here and here —of the more than 300 Accelerated Approvals (and withdrawals)): The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. FDA-2022-E-3124 ).

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Clinic IT Provider Patient-Centered 59

FDA Law

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

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Clinic Relationship Provider IT 64

FDA Law

AUGUST 18, 2024

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. calendar years is both inexplicable and deprives patients and clinicians of options. These legislative changes helped. The average annual number of De Novos granted leapt.

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Specialization Hospital Physicals Provider 69

FDA Law

FEBRUARY 21, 2022

Dr. Unger transitioned to the Office of Drug Evaluation-I in 2009, and became its Director in 2012. Drug development attorney (and guru) Frank Sasinowski commented: “We are honored to have Dr. Unger join us in aiding patients, researchers and sponsors bring new therapies to those in need of them.

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Patient-Centered Management Hospital Medical 40

FDA Law

MARCH 1, 2023

In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues. By Holly N.

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Management Manufacturing Supply Chain Provider 45

FDA Law

APRIL 30, 2023

112-144 (2012). Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S. 110-85 (2007), as amended by Section 301 of Pub. Yeah, you read that correctly!

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IT Education Patients Provider 59

FDA Law

FEBRUARY 27, 2024

FDA also approved two NDAs on the same first day for micafungin (MYCAMINE)—NDA 021506 for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, and NDA 021754 for the treatment of esophageal candidiasis. leave you scratching your head (we’ll call it “Who’s Buried in Grant’s Tomb?”).

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Patients IT Provider Individual 59

Pamela Wible MD

JUNE 20, 2025

Dr. Shay’s original definition was based upon his patients’ war narratives and Homer’s Iliad (762 B.C.) (Published 3/18/19, updated 6/20/25) What Is Physician “Burnout”—and Why It Matters Physician “burnout” is a state of emotional, physical, and mental exhaustion caused by prolonged stress in the medical workplace.

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Medical Student Diagnosis Physicals Medical 246

The Health Policy Exchange

MARCH 14, 2013

However, when one of those guidelines suggested that spinal fusion surgery was unnecessary for most patients with acute low back pain, AHCPR found its budget under attack. In July 2012, it was deja-vu all over again as AHRQ's budget was singled out for elimination by an appropriations subcommittee in the House of Representatives.

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DO Family Medicine Screening Medical 130

Common Sense Family Doctor

FEBRUARY 1, 2025

Since the turn of the century, the rise of hospitalists and the corresponding decline in the number of office-based family physicians who provide inpatient care for their own patients has magnified the value of optimizing the handoff from hospital-based teams to primary care physicians.

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Hospital Management Primary Care Primary Care Physician 52

FDA Law

MARCH 13, 2023

Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). After holding a series of these meetings, FDA realized that PFDD meetings were extremely successful and wanted the process to continue.

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Patients Patient-Centered Family Families 98

Common Sense Family Doctor

DECEMBER 4, 2024

A JAMA review article quotes a 2020 American College of Cardiology/American Heart Association guideline as recommending surgical aortic valve replacement (SAVR) for patients younger than 65 years, TAVI for patients 80 years or older, and either procedure in patients 65 to 79 years, depending on operative risk and comorbidities.

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Hospital Management Patients Clinic 52

GeriPal

MARCH 2, 2023

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. There are a lot of reasons that may explain the massive increase in use of these drugs.

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Patient-Centered IT Healthcare Medical 96

Physician's Weekly

JUNE 19, 2025

Frail patients often have compromised immune responses, which increases their vulnerability to infections and reduces their ability to recover from acute respiratory illnesses (ARIs), including influenza and respiratory syncytial virus (RSV), the researchers continued. Data came from the three influenza seasons from 2012 to 2015.

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Illness Hospital Management Patients 52

Common Sense Family Doctor

MAY 11, 2025

A less heralded ruling with health implications occurred in 2018, when the Roberts Court held that a prior federal law forbidding states to legalize sports betting was unconstitutional.

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Management Referral Mental Health Community 52

Permanente Medicine

APRIL 29, 2025

Early screening helps erase racial health disparities The study showed a significant reduction of colorectal cancer deaths among Black patients, which decreased from 52 per 100,000 in 2009 to 23.5 Deaths per 100,000 for Hispanic, white, and Asian patients decreased to 20 during the same time period.

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Screening Checkup Integrated Care Electronics 52

PEMBlog

JUNE 2, 2025

Upon entering the room, you find the patients nurse at the bedside already in mid-conversation with the patients parent. In pediatric patients, this condition should be considered when blood pressure exceeds the 95th percentile for age, height, and sex by more than 30 mm Hg, or reaches levels above 180/120 mm Hg in older adolescents.

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Hypertension Management Physicals Lab Testing 75

Annals of Family Medicine

NOVEMBER 20, 2024

Some research has found lower HPV vaccine uptake in Latino patients and others have demonstrated higher uptake by Latino subgroups. Results Among both male and female patients, all Latino/a groups had higher odds of vaccine initiation and of ? Dataset OCHIN electronic health record data from 27 US states.

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Vaccination Community Clinic Screening 130

FDA Law

FEBRUARY 9, 2022

12, 2012) (quoting Bob’s Pharmacy & Diabetic Supplies; Revocation of Registration, 74 Fed. DEA investigated Gulf Med because it was one of the top ten purchasers of oxycodone, hydromorphone and hydrocodone in Florida. The person who knowingly fills such prescription is subject to administrative, civil and criminal penalties.

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IT Insurance Government Patients 40

GeriPal

FEBRUARY 2, 2024

First, in our editorial, we expressed concern about the length of stay metric not being patient centric, though important for health systems focused on cost savings. Three things I love about this podcast, and why you should listen. It was refreshing to hear Scott and Kate express similar sentiments. Much more to come. Ashwin, welcome back.

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Consulting Hospital Patient-Centered IT 122

PEMBlog

MAY 24, 2023

Patient that are agitated should always be treated with dignity and respect. 2012 Jan;109(3):27-32. Structured team approach to the agitated patient in the emergency department. 2012 Feb;13(1):35-40. The combative multitrauma patient: a protocol for prehospital management. Deaths due to physical restraint.

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Management Patient-Centered Physicals Transportation 54

PEMBlog

DECEMBER 14, 2023

2012 Oct;147(4):619-26. Tracheomalacia and bronchomalacia in children: incidence and patient characteristics. Laryngomalacia, is the most common cause of infant stridor. Early diagnosis is crucial as it can impact a child’s growth and development. Available from: [link] Hartl TT, Chadha NK. Otolaryngol Head Neck Surg.

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Diagnosis IT Diagnose Patients 52

PEMBlog

JUNE 5, 2024

Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2012 Jan 13;61(RR-1):1-20. The most common injuries seen in these younger patients are growth plate fractures and ligamentous injuries. Cervical Spine Injuries are fortunately rare in children. MMWR Recomm Rep.

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Patient-Centered Patients IT Hospital 52

The Clinical Problem Solvers

NOVEMBER 16, 2020

How is racism causing the outcomes that I am seeing in my patient? – Recognizing that racism, not race, is the root cause of racial health disparities is the first step to improving health outcomes for Black, Indigenouls People of Color (BIPOC) patients. Edwin Lindo 03:28 ​What is race? How is race a social construct?

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Clinical Practice Clinic Medical Education 52

GeriPal

MARCH 7, 2024

There’s an organization that I took my training from, which began, I want to say, in 2012. But before we jump into that topic, John, do you have the song request for Alex? John: I do. It’s Jimmy Buffett’s song, Bubbles Up. It was on his last album. As you may know, Jimmy Buffett passed away in August of a rare skin cancer.

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Provider Illness IT Healthcare 119

FDA Law

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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Supply Chain Manufacturing Government Hospital 59

GeriPal

MARCH 20, 2025

Recently, discussion has emerged about how these issues intertwine in caring for patients with advancing dementia who have stated that they would not want to continue living in that condition: for those with an advanced directive to stop eating and drinking, how do we balance caring for their rational past self and their experiential current self?

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IT Patient-Centered Patients Medical 89

PEMBlog

APRIL 26, 2023

Kit Carney and Dr. Kristen Humphrey discuss gun violence, its impact on our patients and their families, as well as practical tips on advocating for safe storage of firearms, and how we can support victims of violence. Pediatrics November 2012; 130 (5): e1416–e1423. 2012-2481 Haasz, M., Melzer-Lange, Joseph O’Neil, Wendy J.

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Family Families Mental Health Healthcare 52

FDA Law

JANUARY 11, 2022

Specifically, Amarin alleged that Hikma’s label “teaches CV risk reduction” due to “a notice regarding side effects for patients with CV disease” and an absence of a statement that the generic “should not be used for the CV indication….” Teva from this case. The Court again made sure to emphasize language from GSK v.

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Insurance Patients IT Manufacturing 52