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Some examples of autologous products classified as high risk products are described to show how regulatory requirements have been satisfied to achieve market authorization.
Since the implementation of the European Union (EU) regulation for advanced therapy medicinal products (ATMPs) in 2009, only six ATMPs achieved marketing authorization approval in the EU.
Despite the increased investment in R&D by the industry, the number of new molecular entities (NME) achieving marketing authorization is not increasing.
Our scheme is highly efficient in terms of user revocation and can achieve fine-grained authorization of the search under the distributed multiple-attribute authorized institution.
The ABS Laboratory, University School of Medicine of Poitiers has an governmental authorization to achieve and publish experiments on cadaveric human subjects in accordance the bioethics law in France.
Yet there was no serious diplomatic plan, and Bush pocketed the war authorization to achieve his ultimate goal of regime change.
This scheme is to achieve the requirements of authentication and authorization.
Clearly, Archard needs some strengthening of what the authorization allows; he tries to achieve this by using the idea of a division of labor.
That would allow Massachusetts to exclude certain brand-name drugs from Medicaid, increasing its leverage in price negotiations beyond what it can achieve through existing utilization management techniques like prior authorization.
We achieve this by leveraging software-defined networking (SDN) and token-based authorization.
Richard M. Larrabee, the director of the agency's port commerce department, said that by consolidating earlier projects under way to achieve 45-foot depths with projects made possible by new Congressional authorizations for the 50-foot channel, the agency could not only cut the time required, but also trim the cost to $2.3 billion.
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CEO of Professional Science Editing for Scientists @ prosciediting.com