Animal Testing and Human Health

Maintaining Standards in Biomedical Animal Testing

Maintaining Standards in Biomedical Animal Testing is Crucial

My Life or the Mouse’s: No Contest

Testing of drug therapies and performance of biomedical experiments on animals are givens in the worlds of scientific and medical research. Public outcry and violent attacks compel the enactment of laws and regulations defining limits and appropriateness in biomedical animal testing and experimentation. Nevertheless, the work continues in corporation and university laboratories across the world because the public highly values relief from pain and suffering and saving human lives more than it values animal welfare. Still, scientists and members of the public who are sensitive to the ethical and humane treatment of animals are uneasy about animal research.

Pharmaceutical companies, government health agencies, commercial medical businesses, and military defense agencies, among others, fund animal testing and experiments. If their labs do not set and maintain standards of animal testing, they risk sanctions, plus public outcry, that can damage company reputations. Because this issue affects sales and marketing, handling it requires thoughtful strategizing.

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What to Expect from an FDA Inspection

Prepare for the FDA's Test of Quality

Prepare for the FDA’s Test of Quality

Inspections by the US Food and Drug Administration (FDA) are not new to regulated industries and laboratories, as are compliance, enforcement, and criminal investigations. With the goal of addressing and minimizing significant health risks, an FDA inspection can either make or break a company, making a good and lasting impression or tarnishing its image, costing the company time, money, and business. For pharmaceuticals, laboratories, biotech leaders, and drug companies, proving quality systems is paramount.

Access to FDA guidelines and regulations is only the beginning. To achieve a five-star rating, pharmaceutical industry manufacturers and suppliers need to understand what FDA inspectors are looking for and how to respond to enforcement measures in a timely and effective manner.

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