FDA Law

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 Family Medicine DO Finance 130

Medical Xpress

JUNE 16, 2025

The goal is to support clinical trials and bring in another $50 million in private investment to help ibogaine win approval from the U.S. Food and Drug Administration (FDA). The process could take years. Ibogaine is made from the root of a plant found in Africa. It has been banned in the U.S. Former Texas Gov.

Mental Health 52

Mental Health IT Medical Specialization 52

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 105

IT Patient-Centered Healthcare Illness 105

FDA Law

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”). We do not address the technical and administrative details of the Discount Program here. Final Guidance at 2.

Manufacturing 105

Manufacturing Provider IT Electronics 105

GeriPal

APRIL 14, 2022

Management of chronic pain in the elderly: focus on transdermal buprenorphine. It’s been around for a long time but is acting like the hot new kid in town. Just look at this year’s AAHPM meeting, where it felt like every other session was talking about how hot buprenorphine is right now. But does this drug really live up to the hype?

Illness 102

Illness Patient-Centered IT Patients 102

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. By 2015 that number increased to 4% of US adults. However, most gabapentin prescriptions are written off-label indications.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

JANUARY 16, 2025

We’re going to be talking about the American Geriatric Society position statement on making medical treatment decisions. Alex 02:21 For Eric 02:21 For unrepresented older adults. But before we go into that topic, Tim, I think you have a song request. Tim 02:29 Yeah, it’s such an honor to make a song request. Can you guys do that one?

Patient-Centered 109

Patient-Centered IT Patients Healthcare 109

GeriPal

DECEMBER 8, 2022

Eric’s blog post on Dignity Therapy from 2011. 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. Because that really is what this is about. SPONSOR: .

Patient-Centered 115

Patient-Centered Illness Healthcare IT 115

FDA Law

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

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

FDA Law

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 13, 2023

Summary Transcript Summary Social connections impact our health in profound ways, whether it is the support we receive from family and friends in navigating serious illness, the joy from shared social activities, or connecting with our community. Welcome back, Ashwin. Ashwin Kotwal: Excited to be back. Eric: Now, it’s interesting. Alex: Great.

IT 99

IT Community Patient-Centered Medical 99

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. Cervical Spine Injuries are fortunately rare in children. MMWR Recomm Rep. 2012 Jan 13;61(RR-1):1-20. PMID: 22237112. Ann Emerg Med.

Patient-Centered 52

Patient-Centered Patients IT Hospital 52

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. and the prediction window at 5 years. the survival benefit of being prescribed statins).

Primary Care 40

Primary Care Clinical Practice Electronics Clinic 40

GeriPal

JULY 7, 2022

We discussed the nature of pain, what makes chronic pain different from acute pain, what’s the difference between proprioception, pain, and suffering, and so much more. Haider is a physician at the Brigham and Women’s Hospital, and the VA in Boston. Welcome back to the GeriPal podcast, Haider. It’s just such a pleasure to be back.

Patient-Centered 106

Patient-Centered Physicals IT Patients 106

GeriPal

DECEMBER 1, 2023

Alex: We’re delighted to welcome back Jason Karlawish, who’s a Geriatrician and Professor of Medicine at Penn and Director of the Penn Memory Center. He’s been on several podcasts about this issue. Jason, welcome back to GeriPal. Jason: It’s great to be back, Alex and Eric. Eric: Wonderful. laughter] Heather: Good point.

IT 116

IT Clinic Illness Hypertension 116

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? Pediatr Emerg Care. 2023;39(1):1-5. doi:10.1097/PEC.0000000000002864 0000000000002864 Finkel L, Ospina-Jimenez C, Byers M, Eilbert W. So how common is it for children to be unvaccinated in the United States? Unfortunately.

Vaccination 66

Vaccination Illness IT Clinic 66