FDA Law Blog

AUGUST 2, 2022

Cole providing guidance to U.S. However, in January 2018, then-Attorney General Jeff Sessions rescinded the Cole and Ogden Memos. It is worth noting that the CSA provides that HHS medical and scientific findings on drugs are controlling. 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. Ebola-related stigma in Ghana: Individual and community level determinants. Scholars such as Wen et al.

Community 40

Community Individual Physicals Finance 40

FDA Law Blog

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

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

PEMBlog

OCTOBER 18, 2024

Emergency Care Plans and Advanced Directives Many DMD patients will arrive with comprehensive emergency care plans or letters from their providers. 2018 Oct;142(Suppl 2):S72-S81. 2018-0333I. DMD patients often receive yearly MRIs to monitor their cardiac health, as discrepancies between MRI and echo findings are common.

Patients 52

Patients Complication Management Consulting 52

FDA Law Blog

DECEMBER 13, 2023

Dr. 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

FDA Law Blog

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

Annals of Family Medicine

NOVEMBER 20, 2024

Objective To provide a comprehensive overview of primary care use among community-dwelling persons with dementia in Quebec from 2018 to 2020. Population Studied Community-dwelling persons aged 65 and older with a prevalent diagnosis of dementia on March 1st of 2018, 2019, and 2020. 60.8%, 60.2%, and 58.8%

Primary Care 130

Primary Care Community Family Physician Diagnosis 130

FDA Law Blog

FEBRUARY 28, 2022

The Agency’s goal is demonstrated in its definition of patient engagement: “Patient engagement is defined as intentional, meaningful interactions with patients that provide opportunities for mutual learning, and effective collaborations.” .

Patients 52

Patients Clinic Medical Patient-Centered 52

FDA Law Blog

JULY 10, 2023

By Day 100 If MDUFA Decision is not reached by Day 100, FDA provides Missed MDUFA Decision Communication that identifies outstanding review issues. Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 By Day 90 FDA sends final MDUFA Decision on 510(k).

Provider 75

Provider IT Engineering Medical 75

The Clinical Problem Solvers

DECEMBER 16, 2020

Moreover, center patients not only in discussions about individual decision-making but in constructing and drawing meaning from the research. September 12, 2018. All If you are interested in health equity, recognize that there is a breadth of research established in the fields of health equity, disparities, and structural racism.

Clinic 52

Clinic Education Clinical Practice Patient-Centered 52

FDA Law Blog

APRIL 3, 2022

The prior BOP regulations became effective April 1, 2018, requiring owners to report the loss of any controlled substance, even single doses, to the Board. No one should be surprised that requiring any controlled substance loss, including a single tablet, to be reported, has resulted in thousands of meaningless reports of de minimis losses.

IT 52

IT Provider Medical Individual 52

FDA Law Blog

FEBRUARY 14, 2023

For all qualified health claims, FDA considers the data and information provided in the petition and available to the Agency, including individual reports of human studies, meta-analyses, review articles, and animal and in vitro studies.

Relationship 40

Relationship Provider IT Individual 40

FDA Law Blog

JUNE 29, 2022

The Expedited Programs Guidance describes situations warranting rescission as when emerging data no longer support the BTD, another product gains traditional approval and evidence is not provided that the designated drug may demonstrate substantial approval over the approved product, or when the program is no longer being pursued.

IT 52

IT Clinic Provider Medical 52

FDA Law Blog

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

GeriPal

JUNE 8, 2023

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. And my hypothesis is that’s because it’s no longer the individual managing their own diabetes, it’s the nursing home staff managing their diabetes. Goldilocks zone).

Diabetes 74

Diabetes Management Patient-Centered Family 74

FDA Law Blog

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. A provision has already been included in H.R.

IT 40

IT Patients Provider Individual 40

FDA Law Blog

JUNE 23, 2021

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. However, in the coming days we hope to do so and may provide our thoughts in subsequent posts. 7, 2017).

Patients 52

Patients Patient-Centered Clinic IT 52

FDA Law Blog

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

FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Physician's Weekly

JUNE 22, 2025

These included how well physicians demonstrated respect, listened to individuals, explained information, and spent enough time with them. Similarly, listening was rated lower (β = −0.286, 95% CI = −0.391 to −0.181, P = 0.001), as were explanations provided by clinicians (β = −0.133, 95% CI = −0.267 to −0.000, P = 0.050).

Individual 59

Individual Insurance Education Medical 59

Physician's Weekly

JUNE 19, 2025

Independent Association The study involved analysis of data from 43,842 adults in the National Health and Nutrition Examination Survey (NHANES, 1999-2018). The impact of DII on CHD is more sensitive in individuals with low traditional risk,” the authors concluded. The cohort’s mean age was 49.8±18.1 years; 47.4 % were male, 45.6%

Hypertension 52

Hypertension Individual Diabetes Diagnose 52

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

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

FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. In August 2018, FDA published a notice in the Federal Register granting an alternative under 21 C.F.R.

Medical 59

Medical Manufacturing Individual Provider 59

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. And yet, after assisting the older adult to their feet, the EMS providers would leave. I think, as providers, we don’t get to see that.

Community 115

Community Transportation IT PCP 115

FDA Law Blog

JUNE 24, 2021

Two years later, in 2018, FDA issued a Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices (see our blog post here ). The 2018 report listed several planned actions by the Agency, one of which was to clarify the difference between servicing and remanufacturing.

Manufacturing 52

Manufacturing Medical Provider IT 52

GeriPal

JULY 21, 2022

Eric: For those of you don’t know, Emmy was on our podcast back in 2018 … man, pre-COVID times. That’s where it really gets to this individual risks and balances, individual situation. So that’s a piece that I think is important for providers anywhere along that process to be asking about driving.

IT 102

IT Family Families Diagnosis 102

GeriPal

MARCH 2, 2023

JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. Eric: Any other interesting tidbits or facts that we should know as providers about gabapentin or Lyrica dosing or pharmacology? J Am Geriatr Soc.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

FDA Law Blog

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

The Clinical Problem Solvers

MAY 30, 2022

As healthcare providers, we must listen to our patients and use the power of our presence to see birthing people’s full humanity and empowerment. She urges us to recognize that maternal mortality changes the life trajectories of individuals and communities. Dr. Kozhimannil reminds us that birth is transformative and a gift to witness.

Community 52

Community Patient-Centered Family Families 52

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.

Family 132

Family Families IT Community 132

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

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

AUGUST 17, 2023

So what is the role of individuals like geriatricians in prescribing amyloid antibodies and caring for individuals who are receiving them? And I do think geriatricians need to as individuals make that decision, largely based on their comfort with the diagnostics and the specifics of the therapeutics. I’m a prescriber.

Patient-Centered 98

Patient-Centered IT Clinic Patients 98

GeriPal

FEBRUARY 6, 2025

So for primary care providers, you order that blood test, you own that. So prior to the new criteria that were proposed in 2018, the criteria were the presence of amyloid in tau was the definition of Alzheimer’s disease. Of these interventions in those individuals. And a primary care provider has 18 minutes.

Primary Care 96

Primary Care Diagnosis Screening IT 96

GeriPal

APRIL 24, 2025

Eric 06:58 It could be CPR in an individual with metastatic cancer in the icu. I think they may not be likely to provide much benefit, but because they’re water soluble and you just pee it out, they’re probably not causing much harm, except for potentially financial harm if they’re very costly. Oh, go ahead, Jill.

Patient-Centered 77

Patient-Centered IT Patients Illness 77