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The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines and the like
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- EDQM set to implement European Pharmacopoeia Version 6.8 in June 2010
European Directorate for the Quality of Medicines & HealthCare (EDQM) will
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Bioequivalence Guidelines
The FDA has updated its draft product-specific bioequivalence guidelines in response to public comments posted on its dockets page. The guidelines were made available last year in conjunction with the draft guidance “Bioequivalence Recommendations for Specific Products.” The agency is aiming to develop a full set of online product-specific bioequivalence recommendations that generic drug applicants can use instead of having to submit individual requests for assistance in bioequivalence study design. The agency said the guidelines would be posted on the CDER website first as drafts, and it would accept comments and eventually publish final versions. The FDA’s draft recommendations for bioequivalence testing are available at www.fda.gov/cder/guidance/bioequivalence/default.htm#E. The agency’s original announcement about the bioequivalence guidelines, and the comments that have been submitted, can be found at www.fda.gov/OHRMS/DOCKETS/dockets/07d0168/07d0168.html.
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