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”). Youth behavioral data was not specifically required but FDA encouraged such information.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law Blog

JULY 29, 2024

Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products.

Manufacturing 64

Manufacturing Complication Government IT 64

The Medical Futurist

JUNE 21, 2025

Compared to that, our hearing only processes 11 percent of information, while smell 3.5 Digital contact lenses sound like science fiction: the translucent layer on your eye transmitting special information about your body to an outside device. percent, touch 1.5 percent and taste 1 percent. Don’t you think that’s possible?

Diabetes 105

Diabetes Patient-Centered IT Patients 105

CDOCS

MAY 4, 2021

I diagnosed this case to be complex, requiring extensive bone regeneration, possibly with multiple grafts and informed this patient of the risks, timeline and complexity of his case. The possible complications were communicated so that the patient could make an informed decision and proceed with treatment.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

GeriPal

JUNE 20, 2024

It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit. That can be incredibly informative. We’re doing this also through the inpatient portal because we were trying to get as much information in there as possible.

IT 120

IT Patient-Centered Patients Clinic 120

Physician's Weekly

JUNE 19, 2025

This is the kind of information we all need, all deserve. Because when Bob calls to check on the prior authorization– PA for short– Well, here’s how he says the conversation went… Bob: ‘Yes, we got the PA information. Dan: Another addition: Manufacturer coupons. And maybe we can put a little dent in that.

Insurance 52

Insurance IT Board-Certified Medical 52

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. Ideally, there’ll be a place in the chart that actually captures the name of that person and their contact information. Eric: Susan. Susan: Yeah.

Illness 72

Illness IT Healthcare Patient-Centered 72