By understanding the way the regulatory concepts of safety and effectiveness are interpreted by CDER, especially by the Division of Pulmonary Drug Products, value can be added to the data developed. Keeping regulatory requirements in mind during early product development aids rapid evaluation of aerosol drug candidates and can lead to more efficient decisions about further development. Health care practitioners, the medical research community, and patient advocates can and do have a voice in the development of new regulations.
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US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Draft Guidance for Industry: Bioavailability and bioequuivalence studies for nasal aerosols and nasal sprays for local action. Jun, 1999. http://www.fda.gov/cder/guidance/index.htm.
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US Department of Health and Human Services. Food and Drug Administration. Pediatric Subcommittee of the Medical Policy Co-ordinating Committee. Center for Drug Evaluation and Research in Collaboration with the Center for Biologics Evaluation and Research. Guidance for Industry: Content and format for pediatric use supplements. May, 1996; Available on the internet and by Fax on Demand. http://www.fda.gov/cder/guidance/index.htm.
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US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Draft Guidance for Industry: General considerations for pediatric pharmacokinetic studies for drugs and biological products. Nov, 1998, http://www.fda.gov/cder/guidance/index.htm.
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US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Guidance for Industry: Population pharmacokinetics. Feb, 1999. http://www.fda.gov/cder/guidance/index.htm.
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US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Draft Guidance for Industry: Average, population, and individual approaches to establishing bioequivalence. Aug, 1999. http://www.fda.gov/cder/guidance/index.htm.
