Summary Company Announcement Date: June 28, 2022 FDA Publish Date: June 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Incorrect labeling Company Name: […]

The Biologics Track will focus on the developmental and regulatory topics relevant to cellular and gene therapies, tissue-engineered products, blood products, vaccines, and other biological products. […]

The devices track will provide an overview and highlights of how to get a new medical device to market, discuss some best practices for ensuring that […]

The drugs track will address major advances and innovation across various aspects of the drug development spectrum. Content will provide updates and cutting-edge insight on novel […]

On This Page Date: May 29 – 30, 2024 Day1: Wed, May 29 8:30 AM – 4:30 PM ET Day2: Thu, May 30 8:30 AM – […]

Docket Number: FDA-2021-D-1268 Issued by: Guidance Issuing Office Center for Veterinary Medicine Office of Regulatory Affairs Center for Food Safety and Applied Nutrition This guidance provides […]

Docket Number: FDA-2020-D-2316 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research The intent of this guidance is […]

Docket Number: FDA-2019-D-0934 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes FDA’s current recommendations […]

What are Quality Metrics? For pharmaceutical manufacturing, quality metrics are an objective way to measure, evaluate, and monitor the product and process lifecycle. Quality metrics data […]