FDA Law

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

DECEMBER 12, 2023

In fact, clinical studies estimate that as many as 23% of cats suffer from urolithiasis. We know what you must be thinking: “With all this crystal formation, why don’t they call them Glitter boxes?” (Apologies to our readers—word play is FDA Law Blog’s catnip.)

Utilities 59

Utilities Manufacturing Provider Individual 59

FDA Law

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. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.

Manufacturing 64

Manufacturing Physicals Provider Electronics 64