FDA Law Blog

FEBRUARY 16, 2022

In 2009, Catalyst’s drug Firdapse (amifampridine phosphate) received Orphan Drug Designation for Lambert-Eaton Myasthenic Syndrome (“LEMS”), and FDA subsequently approved Firdapse in November 2018 for the treatment of LEMS in adults with 7 years of Orphan Drug Exclusivity. In that case, Jacobus would need to demonstrate clinical superiority.

Clinic 98

Clinic Patients IT 98

GeriPal

OCTOBER 13, 2022

When I’m on service these days there is inevitably a moment when a resident says “Patient so-and-so is on X” – and I have absolutely no idea what X is. Alex: And we are delighted to welcome Rasheeda Hall, who is a physician scientist in the division of nephrology at Duke University School of Medicine, and sees patients at the Durham VA.

Complication 97

Complication Patient-Centered IT Patients 97

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). for the lidocaine group and 4.8 (0.5)

Patient-Centered 52

Patient-Centered Provider IT Patients 52

CDOCS

APRIL 14, 2021

& When I began practicing in 2009, I joined a practice that had a Redcam in the corner collecting dust.& & Although the Redcam may have left a lot to be desired, my patients and I loved it.& & But, more importantly to me clinically, was the improvement in radiopacity.& Preoperative condition.</span></em></p>

IT 52

IT Patients Provider Appointment 52

PEMBlog

OCTOBER 18, 2023

Neonatal Toxic Shock Syndrome-Like Exanthematous Disease The patient was diagnosed with Neonatal Toxic Shock Syndrome-Like Exanthematous Disease (NTED). This patient was hospitalized for 4 days where he remained well-appearing. Clinical features of neonatal toxic shock syndrome-like exanthematous disease emerging in Japan.

Diagnose 59

Diagnose Diagnosis Illness Patients 59

FDA Law Blog

OCTOBER 4, 2021

Circuit told FDA, for the second time , that the plain text of the Orphan Drug Act unambiguously required FDA to award orphan drug exclusivity to any orphan designated drug, even if that designation was based only on a “plausible hypothesis” of clinical superiority that ultimately could not be confirmed. 6 to less than 17 years of age).

IT 52

IT Patients Provider Manufacturing 52

GeriPal

NOVEMBER 7, 2024

If the purpose of initiating dialysis is improving function – our complex, frail, older patients are likely to be disappointed. Are we seeing people like more older adults, more nursing home patients starting dialysis, and even at a higher gfr? So I wonder if I could turn to either of our nephrologists.

Management 116

Management Patient-Centered Patients IT 116

Permanente Medicine

JUNE 25, 2025

By building an integrated, patient-centered colorectal cancer screening program, we doubled screening rates, cut deaths by 50%, and made major strides in closing racial disparities in outcomes. The approach was simple: consistently alert patients that it’s time to get screened and make getting screened as easy as possible.

Screening 52

Screening Preventive Care Preventative Care Patient-Centered 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.

Screening 52

Screening Checkup Integrated Care Electronics 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.

Patient-Centered 96

Patient-Centered IT Healthcare Medical 96

GeriPal

OCTOBER 20, 2022

And, who within ASPE guides aging policy and connects policy to every day health challenges experienced by patients and clinicians? Alex: And we are delighted to welcome Rasheeda Hall, who is a physician scientist in the division of nephrology at Duke University School of Medicine, and sees patients at the Durham VA.

Complication 52

Complication Patient-Centered IT Patients 52

GeriPal

APRIL 10, 2025

I asked emergency medicine clinicians what they thought when a patient who is seriously ill and DNR comes to the ED, and some responded, (paraphrasing), what are they doing here? Most emergency providers wanted to do the right thing for seriously ill patients, but they didnt have the knowledge, skills, or experience to do it.

Patient-Centered 77

Patient-Centered IT Hospital Patients 77

GeriPal

MARCH 24, 2023

I’m very proud of the work that we do every day and we take care of patients and families no matter where they live or who they are to help them meet their end of life goals. I am passionately against bad care and there is a lot of bad hospice care that preys on highly vulnerable patients and is unnecessary. Eric: Great.

IT 114

IT Provider Patients Families 114

GeriPal

MARCH 7, 2024

Whenever I take care of a patient, I see myself as a family practice doctor, but I’ve been a hospitalist, I’ve been a primary care doctor, and I’ve done palliative. But in the end, I see these as my patients and I’m trying to define what is the right model. I wonder, is this only for patients in hospice?

Provider 117

Provider Illness IT Healthcare 117

GeriPal

MARCH 10, 2022

Now when I say variation, I’m not talking about small little clinically questionable variations. Many years ago for the first study; I believe it was in 2009, 2010; I met with Susan Mitchell at the Institute for Aging Research, and told her that I wanted to study the use of feeding tubes for people with advanced dementia. Ruth: Sure.

Nurse Practitioner 60

Nurse Practitioner Hospital Families Family 60

PEMBlog

APRIL 4, 2025

Unfortunately, timely clinical question, what do we do with the UN or under vaccinated child who presents to the emergency department with fever? Unvaccinated or under vaccinated children are functionally immunocompromised in specific clinical scenarios such as fever without source. So what are we gonna go over in this episode?

Vaccination 68

Vaccination Illness IT Clinic 68