Semantic Scholar Open Access 2019 82 sitasi

Regulating Nanomedicine at the Food and Drug Administration.

J. Paradise

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Abstrak

The US Food and Drug Administration (FDA) oversees safety and efficacy of a broad spectrum of medical products (ie, drugs, biologics, and devices) under the auspices of federal legislation and agency regulations and policy. Complex and emerging nanoscale products challenge this regulatory framework and illuminate its shortcomings for combination products that integrate multiple mechanisms of therapeutic action. This article surveys current FDA regulatory structures and nanotechnology-specific guidance, discusses relevant nanomedicine products, and identifies regulatory challenges.

Topik & Kata Kunci

Medicine Business

Penulis (1)

J. Paradise

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Paradise, J. (2019). Regulating Nanomedicine at the Food and Drug Administration.. https://doi.org/10.1001/amajethics.2019.347

Akses Cepat

Lihat di Sumber doi.org/10.1001/amajethics.2019.347

Informasi Jurnal

Tahun Terbit: 2019
Bahasa: en
Total Sitasi: 82×
Sumber Database: Semantic Scholar
DOI: 10.1001/amajethics.2019.347
Akses: Open Access ✓