New law broadens FDA safety authority, renews user fees
Article Abstract:
The new Food and Drug Administration Amendments Act (FDAAA) was signed into law in September 2007, thereby bringing relief to the biotechnology industry. The act is expected to put new emphasis on drug safety monitoring, hire additional staff for post-market surveillance and modernize its information technology systems.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2007
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Blood products part of FDA xenotransplant plan
Article Abstract:
The US Food and Drug Administration (FDA) recently announced an extensive plan for regulating xenotransplant products and procedures. The agency also sought expert advice on establishing principles for easing those restrictions when xenotransplantation progresses from the mainly experimental stage to being widely used.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2000
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US bioethics committee weighs in
Article Abstract:
The report from the President's council on bioethics provides a precautionary analysis of prospects for using biotechnology to enhance personal health and performance. Two major federal reports, one on bioethics and the other on commercial developments and opportunities are presented.
Publication Name: Nature Biotechnology
Subject: Business
ISSN: 1087-0156
Year: 2003
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