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Working for the US market: Tools and methods for regulatory compliance

: Huen, J.

Bioforum International (2001), Nr.2, S.248-249
Fraunhofer IPA ()
life science product; product quality; Lebensmittelsicherheit; Produktqualität; Arzneimittel; Recht; Gesetz; USA; Lebensmittel

The Food and Drug Administration (FDA) is a federal agency in charge of protecting the American population against the dangers caused by life science products, whether from domestic or foreign origin. As a consequence, European companies working for the US market must obey the rules issued by FDA. This is particularly important in the activities performed by research and control laboratories, as the play a major role in the assurance of product quality and innocuousness. The present article gives an overview of the requirements of FDA and of the methods and tools available for reaching regulatory compliance.