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Abbreviated New Drug Applications (andas annual Report, this reference also explores the pressures affecting the industry and the general public, as well as how these pressures will change regulatory the general nature and specific aspects of submissions the submissions process over guidebook the near future.
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In addition, retired Canadian trade consul and regulatory singer consultant Carl Rockburne guest-authors a chapter comparing the FDA process to the four other major regulatory environments of Canada, the European Union, Japan, and Australia.
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