FDA Law Blog

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.

Manufacturing 115

Manufacturing IT Provider ER 115

GeriPal

JUNE 20, 2024

And that’s what makes these issues so challenging, because at one level, we use the same term to refer to that incredibly multifactorial, complicated, complex condition as we do to stress incontinence, which is also complex in its own way. But the solutions, as we’ll get to in a few minutes, are completely different.

IT 120

IT Patient-Centered Patients Clinic 120

GeriPal

MARCH 24, 2022

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. I know not all systems are set up to allow for that or facilitate that retrieval, which makes things a little bit more complicated when push comes to shove.

Illness 73

Illness IT Healthcare Patient-Centered 73

FDA Law Blog

MAY 21, 2024

DEA noted that “there is considerable variability in the cannabinoid concentrations and chemical constituency among marijuana samples and that the interpretation of clinical data related to marijuana is complicated.” NPRM at 44,607.

Physicals 69

Physicals Medical Clinic Emergency Room 69

Tiny Physician

OCTOBER 17, 2021

However, there is no clinical trial on its effect on COVID 19 infection or its complications. Later, due to mass outrage from the scientific community, the label of ‘drug for treatment’ was changed to ‘immunity booster’ (5). Without well-designed clinical trials, how can we allow this drug to be given to our children?

Vaccination 52

Vaccination Government Physicals IT 52