FDA Law Blog

NOVEMBER 9, 2023

The FDA Food Safety Modernization Act (FSMA) enacted in 2011, aims to ensure the U.S. As a result FDA can make better informed decisions in managing potential risks of imported food into the United States. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

IT 52

IT Management Provider Patients 52

FDA Law Blog

JANUARY 4, 2023

The Agency referred to its 2011 FDA Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products during the town hall. Per the 2011 FDA Guidance, developers should validate the assay prior to conducting a clinical study that will investigate the efficacy for licensure. Comparability.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

The Health Policy Exchange

JANUARY 3, 2013

As Medicare approaches its 50th anniversary, it faces huge budgetary challenges driven by increasing costs of health care and the demographics of the enormous "Baby Boom" generation, the first member of whom became eligible for Medicare benefits in 2011. Presidents must actively manage the Congressional process. Speed is essential.

Insurance 130

Insurance DO Family Medicine Finance 130

Medical Xpress

JUNE 16, 2025

Ibogaine shows potential for promoting neuroplasticity and aiding recovery, though it carries cardiac risks that require careful management. The initiative aims to attract additional private investment and facilitate FDA approval. This summary was automatically generated using LLM.

Mental Health 52

Mental Health IT Medical Specialization 52

FDA Law Blog

NOVEMBER 14, 2024

trillion health care expenditure is attributed to managing and treating chronic diseases and mental health conditions. However, it’s fair to say that FDA’s food program has focused primarily on implementation of the many mandates in the Food Safety Modernization Act of 2011. About 90% of the annual $4.1

Chronic Disease 64

Chronic Disease Chronic Condition Hypertension Mental Health 64

FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Kirschenbaum — The Inflation Reduction Act (IRA) significantly changed the Part D benefit.

Manufacturing 105

Manufacturing Provider IT Electronics 105

FDA Law Blog

FEBRUARY 5, 2024

If expanded choices are desirable, FDA recommends following the standards from the 2011 HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status and provides more detailed categories from that guidance. describe the sociocultural construct of our society.”

Clinic 59

Clinic Medical Provider Management 59

GeriPal

APRIL 14, 2022

Management of chronic pain in the elderly: focus on transdermal buprenorphine. And how am I going to manage their pain? And then part of our role as folks in palliative care who as Katie mentioned, really try to help folks manage distress around serious illness. Two great videos on buprenorphine initiation. Transcript.

Illness 103

Illness Patient-Centered IT Patients 103

Medical Xpress

JUNE 8, 2025

The commonest strategy to manage acute pain in preterm babies is to give them sucrose , a sugar solution. One of these sites does not use sucrose for acute pain management. We found no link between preterm babies later behavior and how much sucrose they were given to manage pain. Whats more, pain isnt always managed.

IT 53

IT Management Vaccination Medical 53

GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. Even in the crazy hurried clinic space, the interesting thing, I have had two or three outpatient clinic managers email me that said, “I saw this narrative.” About us – Dignity in Care. Research Team – Dignity in Care. Other links: Curiosity by Faith Fitgerald.

Patient-Centered 116

Patient-Centered Illness Healthcare IT 116

GeriPal

MARCH 2, 2023

2022 Perioperative Gabapentin Use in Older AdultsRevisiting Multimodal Pain Management JAMA IM. 2011-2014 JAMDA 2020 Efficacy of Gabapentinoids: Gabapentinoids for Pain: Potential Unintended Consequences. J Am Geriatr Soc. JAGS 2022 Trends in Antipsychotic and Mood Stabilizer Prescribing in Long-Term Care in the U.S.:

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

JANUARY 16, 2025

And so there’s complexity in Understanding how each state manages this. You know, baby boomer generation started to turn 65 and older back in 2011. So on the clinical side, people are really focused on how long do they have to be on the ventilator and managing that. Because I mean, California is different.

Patient-Centered 110

Patient-Centered IT Patients Healthcare 110

PEMBlog

JUNE 5, 2024

Guidelines for field triage of injured patients: recommendations of the National Expert Panel on Field Triage, 2011. 2011 Aug;58(2):145-55. Let’s go ahead and pivot to initial management. MMWR Recomm Rep. 2012 Jan 13;61(RR-1):1-20. PMID: 22237112. Ann Emerg Med. doi: 10.1016/j.annemergmed.2010.08.038. 2010.08.038.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

GeriPal

DECEMBER 15, 2022

Even in the crazy hurried clinic space, the interesting thing, I have had two or three outpatient clinic managers email me that said, “I saw this narrative.” We need to remedy that issue, Eric. We need to get Harvey on GeriPal. You did write a blog post about him though, Eric.

IT 106

IT Patient-Centered Healthcare Illness 106

GeriPal

APRIL 13, 2023

And so we essentially leveraged the National Health Aging Trend Study and looked over from a period from 2011 to 2019 to essentially look at the trajectory of people developing dementia in the sample over time. For example, I also recently published a meta-analysis on psychosocial interventions in medical settings.

IT 100

IT Community Patient-Centered Medical 100

BMJ

JUNE 25, 2021

This can also be seen in the sequential treatment decisions in managing cardiac risk 3 and the alternating statin therapy usage. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. www.statisticsauthority.gov.uk/assessment/code-of-practice Eur Heart J. 2020;41(1):111-188.

Primary Care 40

Primary Care Clinical Practice Electronics Clinic 40

GeriPal

JULY 7, 2022

And then once I came to the United States, I saw this whole different dimension of pain, because I started residency in 2011, this was really at the peak of the opioid prescription epidemic, if you may. And the VA has become really the center of excellence for interdisciplinary pain management. And I was an internal medicine resident.

Patient-Centered 106

Patient-Centered Physicals IT Patients 106

GeriPal

DECEMBER 1, 2023

Just for the audience, we’re talking about, the NIA and the AA have been doing these frameworks since what, 2011? I’ve got the Alzheimer’s that has me needing someone to manage my checkbook. Eric: Can I take a step back real quick just for the audience? I’m going to let Heather go next. Mainly for research.

IT 117

IT Clinic Illness Hypertension 117

PEMBlog

JANUARY 17, 2024

2011 Mar;127(3):e573-80. Epub 2011 Feb 21. Clin Infect Dis 2011; 52:e18. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Pediatrics. doi: 10.1542/peds.2010-2053. PMID: 21339275; PMCID: PMC3387913. Pallin, William D.

IT 59

IT Patients Diagnosis Clinic 59

PEMBlog

APRIL 4, 2025

Immunization status and the management of febrile children in the pediatric emergency department: what are we doing? Certainly any child who’s ill appearing or has unstable vitals should be managed for presumed sepsis or septic shock, and that’s not the focus of this podcast episode in well Appearing Children with Fever.

Vaccination 66

Vaccination Illness IT Clinic 66