The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance document entitled ``FDA Recommendations for Sampling and Testing Yellow Corn and Dry-Milled Yellow Corn Shipments Intended for Human Food Use for Cry9C Protein Residues.'' Full document...

This guidance provides you, an establishment that makes donor eligibility determinations for certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations concerning the donor eligibility and additional requirements under Title 21 Code of Federal Regulations, Part 1271, Subpart C (21 CFR Part 1271, Subpart C). Full document...

In a guide such as this, it is impractical to attempt to answer every food labeling question that might arise. The most frequently raised questions have been addressed using a "question and answer" format. We believe the vast majority of food labeling questions are answered. They are grouped by the food labeling area of interest. The Table of Contents will help you locate your food labeling area of interest. Full document...

"A Labeling Guide for Restaurants and Other Retail Establishments Selling Away-From-Home Foods" is intended to be guidance to facilitate compliance with the new regulations. Full document...

This guidance contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. Full document...

This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Full document...

This annex is the result of the Q4B process for Residue on Ignition/Sulphated Ash. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). Full document...