FDA Law

FEBRUARY 28, 2022

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law

AUGUST 2, 2022

Cole providing guidance to U.S. However, in January 2018, then-Attorney General Jeff Sessions rescinded the Cole and Ogden Memos. CRCC also requests such guidance should explicitly protect patients using cannabis for medical treatment. 3 (July 5, 2022) [hereinafter CRCC Letter].

Medical 96

Medical Individual Provider Community 96

BMJ

JULY 17, 2020

A multilayered view of stigmatizing discourses lays the foundation for eliciting a series of suggestions for quelling stigma, to be implemented at the individual, community, and national levels, as suggested by the WHO. How to reduce the negative psychological impact MRSA isolation on patients. Scholars such as Wen et al.

Community 40

Community Individual Physicals Finance 40

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. The practice of medicine was viewed as paternalistic.

Patients 52

Patients Patient-Centered Clinic Community 52

PEMBlog

APRIL 20, 2023

Emicizumab (Hemlibra) was approved in 2018 for routine bleeding prophylaxis in hemophilia A with or without inhibitors. It is therefore no hyperbole to say that Emicizumab has been a life-changing therapy for individuals with hemophilia A who have factor VIII inhibitors (alloantibodies against factor VIII). This is a black box warning.

Individual 52

Individual Patient-Centered Patients IT 52

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

The Clinical Problem Solvers

DECEMBER 16, 2020

19:05 Clarifying the “ethics vs science” argument and critiquing research techniques 22:00 Resurgence of race-based speculation in COVID-19-related research 25:57 Implantation of ideas about innate racial inferiority within medicine 28:32 Will removal of race from algorithms potentially harm our patients?

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law

DECEMBER 13, 2023

Janet Maynard, Director of this Office, highlighted in the press release that “[g]enetic metabolic diseases include very rare diseases that individually affect a limited number of patients. Drug development for these conditions has unique and complex challenges, therefore few treatments are available to patients.”

Patient-Centered 59

Patient-Centered Medical Patients IT 59

GeriPal

JUNE 8, 2023

When I’m on palliative care consults and attending in our hospice unit we have to counsel patients about deprescribing and de-intensifying diabetes medications. Our last podcast was with Laura Petrillo in 2018 – 5 years ago seems ancient history – though many of the points still apply today (e.g. Goldilocks zone).

Diabetes 74

Diabetes Management Patient-Centered Families 74

FDA Law

JANUARY 6, 2022

Wasserstein — “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s blog here. 18 U.S.C. § 18 U.S.C. § 18 U.S.C. §

Lab Testing 40

Lab Testing Individual Referral Patient-Centered 40

FDA Law

JUNE 16, 2023

The statement must itemize the cost components related to production of the drug, identify increases in materials or manufacturing costs, and provide other information that the manufacturer believes relevant to determining whether a violation has occurred. SF 2744 also provides a private right of action to enforce the prohibition.

Manufacturing 45

Manufacturing Provider Consulting IT 45

FDA Law

SEPTEMBER 20, 2021

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law

MAY 17, 2022

FDA approved FIRDAPSE in November 2018, with a period of orphan drug exclusivity, for the treatment of Lambert-Eaton Myasthenic Syndrome (“LEMS”) in adult patients. And UFA reauthorization provides the perfect vehicle for the Agency to try and get this accomplished. and more likely 15-20. and more likely 15-20. Becerra.”

IT 40

IT Patients Provider Individual 40

FDA Law

FEBRUARY 27, 2024

For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. 2018) , Arnold Partnership v. See Lourie, Patent Term Restoration: History, Summary, and Appraisal, 40 Food, Drug, and Cosm.

Patients 59

Patients IT Provider Individual 59

The Clinical Problem Solvers

FEBRUARY 8, 2023

Between 2007 – 2019, Black individuals experienced a higher death rate for opioid overdose deaths than any other racial or ethnic group. These narratives have vilified individuals who would benefit from comprehensive, person-centered substance use treatment, rather than incarceration and other adverse harms.

Community 52

Community Patient-Centered Mental Health Board-Certified 52

Physician's Weekly

JUNE 19, 2025

Due to the inclusion of multiple variables, guiding patients on diet based on DII becomes more complex.” Independent Association The study involved analysis of data from 43,842 adults in the National Health and Nutrition Examination Survey (NHANES, 1999-2018).

Hypertension 52

Hypertension Individual Diabetes Diagnose 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. Going into patient’s homes was eye opening. And yet, after assisting the older adult to their feet, the EMS providers would leave.

Community 115

Community Transportation IT PCP 115

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.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

BMJ

FEBRUARY 8, 2021

Two out of three drug overdose deaths in 2018 involved an opioid – be it prescription opioids, heroin, or synthetic opioids. 6 As a result of these and many other actions, the death toll from opioid overdose fell by more than 4% between 2017 and 2018. 2 Opioids contribute a large share of this overdose crisis.

Medical 40

Medical Holistic Care Healthcare Healthcare Professional 40

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. Initially, it was just because there weren’t really answers for my patients. That’s where it really gets to this individual risks and balances, individual situation. Weren’t those the days?

Families 102

Families IT Family Diagnosis 102

FDA Law

OCTOBER 17, 2023

FDA previously released the final guidance document in December 2018 outlining the program’s principles, features, designation criteria, and other considerations. Additionally, the 2022 draft guidance suggested the addition of a new section to the 2018 guidance on reducing disparities in health and healthcare.

Medical 53

Medical Diagnosis Healthcare Clinic 53

GeriPal

JUNE 22, 2023

Michele: Yeah, so in May of 2018, there was an article by Suleika Jaouad in the New York Times Magazine, and they spent about two weeks in our hospice with us learning about the work that’s done. Michele: The article was 2018, but I think Bonnie read the article more recently. Eric: How long ago was this? Alex: A few years back.

Families 132

Families Family IT Community 132

The Clinical Problem Solvers

MAY 30, 2022

We all must recognize the codification of racism within our institutions and work to unlearn these hierarchies in order to better care for Black and Indigenous patients. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. The practice of midwifery in rural US hospitals.

Community 52

Community Patient-Centered Families Family 52

GeriPal

APRIL 3, 2025

We covered: The first parody song I wrote, for AGS 2018 in Orlando , about this article by Nancy Schoenborn on how to discuss stopping cancer screening. Annie 02:31 So if you go to the A G S meeting every year, you know that this group of three individuals comprises the AGS literature update. Alex joined in 2018.

IT 64

IT Hospital Screening Patients 64

GeriPal

APRIL 24, 2025

We and our guests have noticed that in our clinical practices, patients and caregivers seem to be asking for such treatments more frequently. If its potentially unsafe, but has robust evidence, well thats most of the treatments we offer seriously ill patients! Think chemotherapy to imminently dying patients, or CPR. Think chemo.

Patient-Centered 77

Patient-Centered IT Patients Illness 77

GeriPal

AUGUST 17, 2023

However, as noted in our editorial published with the donanemab trial , the modest benefits of amyloid antibodies would likely not be questioned by patients, clinicians, or payers if amyloid antibodies were low risk, inexpensive, and simple to administer. I think geriatricians seed to decide whether they want to get on board as individuals.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

GeriPal

FEBRUARY 6, 2025

That screening influences kind of further treatment, actually, probably more importantly, patient outcomes. And when I asked the patient, well, what happened, the test was sprung on them. Well, even for somebody like you, who’s pretty familiar with the instruments, it might cause distress for the patient, maybe their family.

Primary Care 96

Primary Care Diagnosis Screening IT 96

GeriPal

MARCH 24, 2022

2018 Systematic Review of Systematic Reviews on ACP. Although, certainly when you start facing complications of serious illness, it is increasingly important to engage as individuals and conversations about goals, values, and preferences. Alex: What did it changed to after 2018? We can work it out! AlexSmithMD. Transcript.

Illness 73

Illness IT Healthcare Patient-Centered 73

GeriPal

MARCH 3, 2022

This idea that for critically ill patients in the ICU, geriatric conditions like disability, frailty, multimorbidity, and dementia should be viewed through a wider lens of what patients are like before and after the ICU event was transformative for our two guests today. I want to say like 2017, 2018, something like that.

Patient-Centered 96

Patient-Centered Patients IT Illness 96

GeriPal

MAY 12, 2022

When we think about palliative care delivered here, like individuals with chronic pain, non-serious illness chronic pain, non-life threatening illness, oftentimes if we get consulted on them, we don’t even see them, may just be discontinued in most palliative care places. Tom: I have another question about the book.

Community 115

Community IT Relationship Healthcare 115

GeriPal

OCTOBER 3, 2024

Alex 00:08 UCSF’s Division of Palliative Medicine are looking to build on their research and clinical programs and are interviewing candidates for the associate chief of research position and for full time physician faculty to join them in the in-patient and out-patient settings. Frank, welcome to the GeriPal podcast.

IT 122

IT Patient-Centered Patients Relationship 122

Family Medicine Initiative

APRIL 10, 2024

Having Your Own Long-Term GP Can Save Your Life Patients who choose a GP rather than a specialist as their primary care provider have a 19% 8 lower mortality and produce 22% 9 -33% 8 lower healthcare spending. million people in 2018), shows that the longer you know your GP, the better off you are. Over time, more trust develops.

Family Physician 130

Family Physician Families Family GP 130

GeriPal

MARCH 27, 2025

Only 5% of intervention patients received the facilitator-led component of the intervention (there were other components, facilitator-led was the most engaged component). I’m hearing dementia patients or patients with dementia. Eric 09:15 And then who were the patients just with dementia or were they. Is that right?

Primary Care 79

Primary Care IT Clinic Illness 79

PEMBlog

DECEMBER 4, 2024

This episode also covers what healthcare providers need to know about post-exposure prophylaxis, respiratory precautions, and managing occupational exposures. Pediatr Rev May 2018; 39 (5): 247–257. An alternative treatment, you would be trimethoprim sulfamethoxazole for patients who are allergic to macrolides.

IT 52

IT Vaccination Diagnosis Complication 52

Physicians News Digest

APRIL 3, 2025

The episodes turned both women into advocates for patients and spurred research that made American health care safer. Haskell, of Columbia, South Carolina, has done research and helped write AHRQ-published surveys and guidebooks on patient engagement for hospitals. It also has published tools and guidelines to enhance patient safety.

Patient-Centered 52

Patient-Centered Hospital Diagnose Medical 52

FDA Law

SEPTEMBER 13, 2021

In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs , but the edifice envisioned by the Blueprint largely failed to materialize. Controlling Medicare Part D Patient Out-of-Pocket Costs and Total Drug Costs.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98