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In addition to possible national security concerns, there are signi cant economic pressures to create IT architectures and application suites that provide secure collaborative environments. For example, in an effort to in ternationalize clinical trials, guidelines have been established by the Inter national Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) for an electronic common technical document (eCTD) for pharmaceutical companies. The initial guidelines for a uni ed document designed to facilitate new drug submission and data collection from international collaborations, were approved in 2002. Backers of the common electronic technical docu ment include the European Commission, Japanese Ministry of Health, La bor and Welfare, U.S. Food and Drug Administration, European Federation of Pharmaceutical Industries and Associations, Pharmaceutical Research and Manufacturers of America, and Japan Pharmaceutical Man ufacturers Association. This standard, which has parallels in other indus tries, such as nance, requires an architecture and an integration scheme that allow multiple clinical trials to be coordinated at multiple research centers using a variety of standard applications and processes that enable research organizations to share research results with each other.
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As discussed in 2, legal maneuvering by the pharmaceutical com panies that can extend the patent protection of a drug by a few months can result in billions of added revenue. The legal-regulatory infrastructure in biotech encompasses the people and processes that bring the technology to bear on biotech challenges and opportunities. Laws and regulations re ect and shape public opinion toward biotech and provide nancial incen tives for some corporate activities and deterrents for others. Rules regarding monopolies and other forms of unfair competition, taxation, and other business matters at the local, state, national, and international levels de ne the playing eld of business. This section reviews the key legal-regulatory infrastructure agencies that affect the U.S. biotech in dustry. These are listed in Figure 5.2. Although the discussion is focused on the United States, the basic agencies or their functions comprising the legal-regulatory infrastructure exist to some degree in the members of the European Union, Japan, and many other countries.
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Hundreds of federal, state, and local regulatory agencies de ne the legalregulatory environment for pharmaceuticals, agricultural biotech, and
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Agencies Food and Drug Administration (FDA) U.S. Patent and Trademark Of ce (USPTO) Environmental Protection Agency (EPA) Food and Drug Administration (FDA) U.S. Department of Agriculture (USDA) World Health Organization (WHO) National Institutes of Health (NIH) World Health Organization (WHO) World Health Organization (WHO) Environmental Protection Agency (EPA) Environmental Protection Agency (EPA) U.S. Department of State Federal Communications Commission (FCC)
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FIGURE 5.2 Key agencies de ning the biotech infrastructure.
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medical biotech. For example, in the pharmaceutical industry, the key agencies that de ne the business parameters include the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Of ce (USPTO), as listed in Figure 5.2. The FDA, which is part of the U.S. Department of Health and Human Services (HHS), is responsible for promoting and protecting the public health by helping safe and effective products reach the market in a timely way, and by monitoring products for continued safety after they are in use. Its reach extends from food, drugs, and medical devices to biologics, ani mal feed and drugs, cosmetics, and radiation-emitting products. In the realm of pharmaceuticals, the FDA regulates the drug development process to ensure patient safety. FDA oversight includes preclinical safety assess ment, preapproval safety assessment in humans, safety assessment during regulatory review, and postmarketing safety surveillance. The goal of preclinical safety assessment is to identify drugs that are ef fective against a targeted disease in animals without causing signi cant toxicity. Preapproval safety assessment in humans involves a lengthy clini cal trial process culminating in the preparation of a New Drug Application (NDA) seeking FDA approval for manufacturing, distributing, and mar keting a drug in the United States. During the approval process, pharma ceutical companies must supply the FDA with any additional safety information that it obtains. Postmarketing safety surveillance, also known as Phase IV trials, may be required by the FDA or conducted voluntarily by the pharmaceutical company, depending on the frequency and severity of reactions noted in the clinical trials. Postmarketing surveillance is highly
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