Anne Dupraz Poiseau, Anne Virginie and Stuart Mudge report on efforts to create legal definitions for human tissue-engineered and cell therapy products.

Anne Dupraz-Poiseau, Anne Virginie, Stuart Mudge

2004 - The Regulatory Affairs Journal
The...

Despite the increasing range of guidance documents available, and the best efforts of those involved in producing them, product development sponsors are often faced with challenges that require a “case-by-case” and a “scientific-based” approach.

Stuart Mudge...

Technical advancements in molecular and cellular biology have the potential to provide an amazing array of human tissue engineering products (hTEP), and in doing so may revolutionize medical practice. The range of potential applications and the marketing potential...

Innovative therapies pose special problems for drug developers and regulators alike. By definition, such therapies tend to leap forward into unregulated or incompletely regulated territory. Orphan drugs often fall into the category of “innovative therapies” and...

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