The procedure of genetic engineering uses recombinant DNA for introducing new characteristics or traits into an animal. The new guidance, Guidance for Industry #187 - Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs, provides all the needed details, so that the producers of these animals will know what to do in order to get the FDA's approval. Moreover, producers of these animals will also have to follow the law and regulations of the National Environmental Policy Act.
I think these are truly remarkable times in the life of scientific discovery. Do you find these advances astounding or troubling?
More Information & Related Posts:
From the FDA: Genetically Engineered Animals
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Monday, January 19, 2009
FDA Final Guidance On Genetically Engineered Animals
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How to Fail an Fda Quality Audit: A Look at Some of the Causes of Failure to Comply With Fda Quality Regulations
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How to Develop and Manage Qualification Protocols for FDA Compliance
Agent GXP FDA Part 11 Guidebook: The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, Medical Device, Food, ... Trials and GCP (Good Clinical Practices)
Development of Fda-Regulated Medical Products: Prescription Drugs, Biologics, and Medical Devices
FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics
Design and Analysis of Clinical Trials: Concepts and Methodologies (Wiley Series in Probability and Statistics)
Clinical Studies Management: A Practical Guide to Success
Analytical Chemistry in a GMP Environment: A Practical Guide
Process Validation in Manufacturing of Biopharmaceuticals: Guidelines, Current Practices, and Industrial Case Studies (Biotechnology and Bioprocessing Series)
Pharmaceutical Equipment Validation: The Ultimate Qualification Guidebook
Preclinical Drug Development (Drugs and the Pharmaceutical Sciences)
Group Sequential Methods: Applications to Clinical Trials (Chapman & Hall/Crc Interdisciplinary Statistics Series)
Validation Standard Operating Procedures: A Step by Step Guide for Achieving Compliance in the Pharmaceutical, Medical Device, and Biotech Industries, Second Edition
Pharmaceutical Stress Testing: Predicting Drug Degradation (Drugs and the Pharmaceutical Sciences)
Cleaning Validation: A Practical Approach
Validated Cleaning Technologies for Pharmaceutical Manufacturing
Risk-Based Compliance Handbook
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume I (1)
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded (Volume 2)
Bioprocess Validation: The Present and Future
Laboratory Validation: A Practitioner's Guide
Quality Assurance Workbook for Pharmaceutical Manufacturers
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ISO 13485 and FDA QSR Internal Audit Checklist
ISO 13485:2003 & FDA QSR (21 CFR 820) Quality Manual, 34 Procedures and Forms
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Planning Programs for Adult Learners: A Practical Guide for Educators, Trainers, and Staff Developers, 2nd Edition
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