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

CDOCS

MAY 4, 2021

He presented with a high smile line and desired fixed natural appearing teeth. The possible complications were communicated so that the patient could make an informed decision and proceed with treatment. Various options were communicated for the posterior teeth which could be considered in the future.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52

FDA Law Blog

JANUARY 11, 2024

Important to note here is that each interchangeable biosimilar was first approved as a biosimilar and each biosimilar manufacturer had been sued under the so-called “patent dance” procedure prior to seeking licensure of the biosimilar products as interchangeable. This all sounds complicated, I know.

Provider 59

Provider IT Manufacturing Complication 59

GeriPal

JUNE 20, 2024

Incontinence and avoiding issues can present in an older individual, in some cases, just like they do a younger person. But then there is incontinence, which is the same term, same word, but actually presents as a geriatric syndrome. Most of the trials that have been conducted are conducted by the manufacturers of those medications.

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 72

Illness IT Healthcare Patient-Centered 72

FDA Law Blog

MAY 21, 2024

The Attorney General, after considering HHS’ recommendations, “concludes that there is, at present, substantial evidence that marijuana does not warrant control under schedule I.” The Attorney General also released DOJ’s Office of Legal Counsel (“OLC”) opinions providing the rationale and support for the NPRM. NPRM at 44,619. 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. It is worth noting that Covaxin, our indigenously developed vaccine manufactured by Bharat Biotech, is on the verge of getting approval in the pediatric age group as well (6).

Vaccination 52

Vaccination Government IT Physicals 52