FDA Outlines Rules on Genetically Engineered Animals - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Outlines Rules on Genetically Engineered Animals


ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (Sept. 24)—In an effort to clarify its policy on the use and creation of genetically engineered (GE) animals, the US Food and Drug Administration released the draft guidance The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs on Sept. 18, 2008. The guidance also outlines requirements and recommendations already existing in regards to GE animals and products derived from GE animals.

GE animals are animals whose DNA has been manipulated with a recombinant DNA (rDNA) construct to bring about new or specific traits. These animals are used to create pharmaceuticals, serve as models for human diseases, and produce consumer products.  According to FDA, rDNA constructs meet the definition of a new animal drug under the Food, Drug, and Cosmetic Act (FD&C Act), which classifies “articles (other than food) intended to affect the structure or any function of the body of man or other animals” as drugs. 

“Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and FDA has long been involved in the scientific evaluation. Our guidance provides a framework for both GE animals and products made from them to reach the market,” stated deputy commission for policy Randall Lutter, PhD, in a press release.

The guidance indicates areas in which FDA will be coordinating with other federal agencies in the US Department of Agriculture and the Environment Protection Agency to develop policies in regard to GE animals. Specific questions addressed in the guidance include FDA’s enforcement entitlements, current regulations, and product development processes. The guidance also outlines the responsibilities for meeting environmental assessment under the National Environmental Policy Act for those applying for an animal drug application.  The draft guidance is limited to heritable rDNA constructs. Nonheritable constructs may be addressed in a future guidance.

Public comment on the draft guidance is open until November 18, 2008. A copy of the guidance can be downloaded here.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here