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Submission and Development

The Federal Food, Dmg and Cosmetic (FDAC) Act defines dmgs as "...articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man..." and "articles (other than food) intended to affect the stmcture of any function of the body of man." In the United States and elsewhere, the introduction of a new dmg is subject to a sequence of weU-defined stages of development and approval (4). Each stage involves either scientific testing or submission and preparation of data and analysis review (Fig. 2). [Pg.267]

You must keep a copy of each report. In addition, you must keep the supporting materials used to develop the Information contained in the report. These records must be kept at the facility for a period of three years from the date of the submission and must be readily available for Inspection by EPA. [Pg.21]

Webster defines "harmony" to mean "correspondence, accord. . . [as in] lives in harmony with her neighbors. " Thus, to "harmonize is "to bring into consonance or accord. The term "accord" is defined as "balanced interrelationship harmony."(37) None of those persons active in international discussions concerning the regulation of new chemicals has argued that "harmonization" will result in the development of any standardized, world-wide scheme for the submission and review of PMN s. Rather, most have viewed harmonization as being goal-oriented — in the words of one OECD official,... [Pg.53]

Meanwhile, chemical innovation goes on. Expectations are set, confidences shared, submissions to Government made, and work proceeds normally with research and development. A new social policy favoring disclosure may be in the works, while somewhere in China a factory manager is wondering what mysterious measures the Western Countries will come up with next. This worldwide concern will be with us for years to come. [Pg.140]

Ten-year trends in NME submissions to FDA and U.S. pharmaceutical research spending. The figure shows 10-year trends in U.S. pharmaceutical research and development (R D) investment (PAREXEL s Pharmaceutical R D Statistical Sourcebook 2002/2003) and the number of submissions to FDA of new molecular entities (NMEs), defined as drugs with novel chemical structure. (Redrawn from http //www.fda.gov/ oc/initiatives/criticalpath/whitepaper.html.)... [Pg.57]

The productivity of research and development efforts within the pharma industry has declined significantly in the past decade. While large numbers of INDs are submitted each year, only a small proportion in the pipeline emerges as NDA submissions or approvals. NDA submissions have fallen by half, from a high of 50 in 1995,... [Pg.623]

Mobil Research and Development Corporation. TSCA sec. 8(e)Submission 8EHQ-0381-0366 Follow-up. A Five Day InhalationToxicity Study of MCTR-174-79 in the Rat. Performed by Bio/dynamics Inc, Washington, DC, Office of Toxic Substances, US Environmental Protection Agency, 1981... [Pg.269]

A great majority of botanical sponsors have taken advantage of the pre-IND consultation service provided by FDA. As a result, most IND applications were successful with initial submission and few (less than 20) were placed on clinical hold for safety concerns. However, despite the early success, many development programs and research projects have subsequently been suspended for various reasons. As of the above-mentioned cutoff date (April 30, 2004), nearly two-thirds (66%) of INDs still remain active (have not been placed on clinical hold, inactivated by FDA, or withdrawn by sponsor for lack of activities). To date, there have been no submissions of NDAs to FDA for marketing approval of botanical prescription drugs. [Pg.324]


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