FDA Law Blog

JANUARY 4, 2023

Brevig, Senior Regulatory Device and Biologics Expert — On December 7, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to cell therapy and tissue-engineered products chemistry, manufacturing, and contr­­ols (CMC).

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MAY 20, 2021

Investigators likely consult with DEA headquarters about the registrant’s compliance with required reporting and review its registration category, status, and authorized controlled substances to assess whether it may be conducting unauthorized activities. Accountability Audit.

Management 40

Management Consulting Provider Physicals 40

FDA Law Blog

MARCH 20, 2022

Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA maintains a database for recalls of FDA-regulated products based on information gathered from press releases and other public notices. “It It is critical for firms in a product distribution chain to be “recall ready.””.

Electronics 40

Electronics Manufacturing Provider IT 40

GeriPal

MAY 5, 2022

And one of the parts of that was actually doing physicals for the students and putting them in job placements. And when you think about that, they’re hearing pieces of the information and their brain is trying to make sense of it. It’s because they literally couldn’t access the information. Eric: Great.

IT 102

IT Screening Hospital Clinic 102

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations.

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

GeriPal

MAY 8, 2025

Alex 06:03 Is psilocybin that’s used for medicinal purposes in your studies, for example, is that manufactured or is it derived directly from mushrooms? This hypothesis Played itself out in an interesting way, Ali John 11:15 Thinking about total pain and addressing physical, emotional, social, and spiritual issues.

Illness 107

Illness IT Patient-Centered Patients 107