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.

Legal issues & crime, Government regulation, Legal/Government Regulation, Laws, regulations and rules, Biotechnology industry, Biotechnology industries, United States. Food and Drug Administration, Drug approval

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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.

DNA Clones

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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.

Management dynamics, Molecular Biological Products, Analysis, Management, Reports, Medical policy, Health policy, Company business management, Biotechnology, Bioethics

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