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Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics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. Part 601 delineates those changes as being either major, moderate, or minor.

Manufacturing 64

Manufacturing Complication Government IT 64

GeriPal

JUNE 20, 2024

On our last podcast about urinary incontinence the song request was, “Let it go.” This time around several suggestions were raised. Eric suggested, “Even Flow,” by Pearl Jam. Someone else suggested, “Under Pressure,” but we’ve done it already. We settled on, “Oops…I did it again,” by Britney Spears. I suggested even flow. That’s a good one.

IT 120

IT Patient-Centered Patients Clinic 120

CDOCS

MAY 4, 2021

The possible complications were communicated so that the patient could make an informed decision and proceed with treatment. This unexpected complication set the restorative phase of treatment back a couple of months, but the results were favorable after 6 weeks verified with 3D imaging.

Patient-Centered 52

Patient-Centered Patients Manufacturing Clinic 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.

Provider 59

Provider IT Manufacturing Complication 59

Physician's Weekly

JUNE 19, 2025

In January of last year, Cole went to a Walgreens in Appleton, Wisconsin, to get refills on the medication he used to control his asthma. He’d been taking it for years, and he expected to pay about seventy bucks. He’d have to pay more than 500 dollars. He left without it. A few days later, he had a massive asthma attack.

Insurance 52

Insurance IT Board-Certified Medical 52

GeriPal

MARCH 24, 2022

All decisions are made in advance, the question that we are debating is how far in advance and what to call it. Completion of advance directives and billing codes for advance care planning as quality metrics. Among other topics. We can work it out! Links to a few couple items mentioned on the podcast: Objectives for Advance Care Planning.

Illness 72

Illness IT Healthcare Patient-Centered 72

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.” and lacked accepted safety for use under medical supervision. 21 U.S.C. § 21 U.S.C. § NPRM at 44,619. NPRM at 44,601.

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). Dipankar et.

Vaccination 52

Vaccination Government IT Physicals 52

FDA Law Blog

OCTOBER 14, 2022

But if you are a medical product manufacturer, the news of the termination of COVID-19 PHE could complicate your business plan. By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “We still have a problem with COVID. We’re still doing a lot of work on it. But the pandemic is over. And so I think it’s changing.”.

Medical 98

Medical Provider Manufacturing Complication 98