FDA Documents

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DocumentTopicDownloadSize
1985 Points To Consider: Production and testing of New Drugs and Biologicals Produced by Recombinant DNA TechnologyDownload0.03 MB
1993 Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals This document supersedes the “Points to Consider (PTC) in the
Characterization of Cell Lines Used to Produce Biologicals (1987)” and
reflects a number of changes emanating from;% several international
workshops held since that time .(1,2).- As stated in the 1987 PTC, the
current approach to working with cell lines to produce biological products
focuses on:
1. production, identification and characterization of the cell substrate;
2. validation of the manufacturing process for removal and/or inactivation of adventitious agents;
3.testing of the bulk and final product to assure safety.
Download0.27 MB
1997 Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human UseDownload0.14 MB
2008 Draft Guidance for Industry: Process Validation: General Principles and PracticesDownload0.01 MB
2008 Guidance for Industry: cGMP for Phase I Investigational DrugsDownload0.13 MB
2008 Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed BiologicsDownload0.09 MB
2008 Guidance for Industry: Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat ProcessesDownload0.07 MB
Points to Consider in the Manufacture and Testing of Therpeutic Products for Human Use Derived from Transgenic AnimalsThis document presents considerations of the Food and Drug Administration (FDA) with regard to the use of transgenic animals to produce FDA-regulated drugs and biological products intended for human use. These considerations include important scientific questions that should be addressed by sponsors during the preparation of IND, PLA, ELA or NDA submissions. This guidance is expected to assist sponsors in determining what scientific data should be submitted in support of applications for new therapeutic products generated in transgenic animals.Download0.18 MB