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1 Jane Henney, Jane Henny Delivers Remarks at the National Press Club, Fed Document Clearing House Pol Transcripts, Dec 12, 2000, at LEXIS, Nexis Library 2 The Food and Drug Administration: An Overview, Ctr For Food Safety & Applied Nutrition (CFSAN Pub No BG 99-2), June 11, 1999, at http://wwwcfsanfdagov/fdaoviewhtml 3 The President s budget request for fiscal year 2004 totals $17 billion, including $14 billion in budget authority and $300 million in user fees See Fiscal Year 2004: Hearing Before the Subcomm on Agriculture of the House Comm On Appropriations, 108th Cong (2003) (statement of Mark McClellan, Commissioner, Food and Drug Administration), at LEXIS, Nexis Library 4 FDA Modernization Act, Pub L No 105-115, 111 Stat 2296 (codified at 21 USC 301 et seq (1994)) [hereinafter FDAMA].

The customer poll method helps build a forecast from the ground up by summing the individual components such as products, stores, or customers. Whole-market penetration, market share, and the chain method are top-down forecasting methods used to predict sales for new products and markets lacking sales data. The strategic modeling method develops a forecast by projecting the impact of changes to pricing and advertising expenditures. Statistical forecasting methods include exponential smoothing, moving averages, and linear regression. You can use the built-in macros to enter data into your forecast automatically. For example, enter values for the first and last months of a 12-month forecast. The compounded-growth-rate macro will automatically compute and enter values for the other 10 months.

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The most significant initiative to enhance the efficiency of drug regulation was the reauthorization of user fees on drug manufacturers FDAMA 101 107 (1994) The legislation also attempted to increase patient access to experimental drugs through the fast-track process and increase the similarities between regulations on drugs and biologics and streamline the approval process for clinical research on drugs and biologics Id at 112, 123(f) ( The Secretary of Health and Human Services shall take measures to minimize differences in the review and approval of products required to have approved biologics license applications under section 351 of the Public Health Service Act (42 USC 262) and products required to have approved new drug applications under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 USC 355(b)(1)) ).

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Testing can be applied to a wide range of development projects in a large number of industries. In contrast to the diversity of testing scenarios and uses is a common underpinning of objectives. The primary motivation for testing all business development projects is the same: to reduce the risk of unplanned expense or, worse, the risk of failure. This primary motivation is divided into four interrelated testing objectives.

In an attempt to streamline the approval process for clinical research on drugs and biologics, FDAMA enables clinical investigations to begin 30 days after the manufacturer provides the FDA with a submission containing required information Id at 117 A manufacturer can request to meet with the FDA to collaborate in designing clinical trials for NDA s and BLA s Id at 119 The legislation also intended to increase the use of scientific advisory panels and simplify the approval process for drug and biological manufacturing changes Id at 120, 116 In addressing regulation of medical devices, Congress authorized the FDA to allow third party review of low-risk 510(k) s and put a higher priority on FDA review of life-saving devices Id at 210, 202 The act directed the FDA to institute early meetings with product sponsors Id at 201, 205.

Finally, the act mandated that the FDA consider the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval Id at 205 The legislation also included several broad policies intended to improve the overall effectiveness of the FDA First, the legislation introduced a process for dispute resolution when a scientific controversy arises between the manufacturer and the agency Id at 404 Second, the legislation placed a strong emphasis on consultation and cooperation with domestic and international entities The Act notes that the FDA should participate with representatives in other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and carry out [its mission] in consultation with experts and in cooperation with consumers, users, manufacturers, importers, packers, distributors, and retailers of regulated products..

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