FDA Issues Final Rule for Records and Reports on Experiences with Animal Drugs
On 31 March, the Food and Drug Administration issued a final rule that reduces the agency's requirements for records and reports on experiences with approved new drugs for animals2. The rule, which goes into effect on 30 June, significantly reduces the previous requirements of both reporting and record keeping on experiences with New Animal Drug Applications (NADA) and Abbreviated NADAs (ANADA), as compared with current regulations, and incorporates many of the industry comments on earlier drafts. This final rule redefines the kinds of information that must be maintained and submitted by new animal drug applicants for an NADA or ANADA. It revises the timing and content of certain reports to enhance their usefulness, provides for the protection of public and animal health, and reduces the record-keeping and reporting requirements.
Sweden Bans Experiments Using Great Apes, Gibbons
Effective in June, great apes and nine species of gibbons will be exempt from use as research subjects in Sweden3. Although none of these species is currently being used in research in that country, the new legislation marks an ideological victory for animal rights organizations that have been campaigning. Sweden joins Great Britain, Japan, New Zealand, and the Netherlands on a list of countries that have outlawed research on these animals. Swedish researchers will still be permitted to use great apes and gibbons in noninvasive behavioral studies.
References
USDA, APHIS. Proposed rule. Animal welfare; medical records. Federal Register 68, 17752–17755 (11 April 2003).
FDA. Withdrawal of interim final rule and issuance of final rule. Records and reports concerning experience with approved new animal drugs. Federal Register 68, 15355–15369 (31 March 2003).
Animal Rights Sweden. Sweden bans experiments on great apes (9 April 2003). http://www.djurensratt.org/articles/article.asp?id=615.
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Shalev, M. Regulation Updates. Lab Anim 32, 16 (2003). https://doi.org/10.1038/laban0603-16b
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DOI: https://doi.org/10.1038/laban0603-16b