FDA expects to issue an advance notice of proposed rulemaking in November requiring ANDA applicants to include data from all bioequivalence studies conducted on a drug formulation with their application.

According to the agency's "unified agenda," published in the May 13 Federal Register, the ANPRM would require ANDA applicants to submit information "from all additional passing and non-passing BE studies conducted on the same drug product formulation submitted for approval."

Current regulations require that only passing BE studies be submitted for ANDA approval. As a result, applicants "have not typically submitted" additional BE studies conducted on the same drug formulation, FDA says. The proposed rule would require such information "in either a complete or summary report."

FDA deemed the rule necessary after several inspections of generic drug facilities revealed that data from failing BE studies had not been submitted to the agency. The data would be useful in helping FDA decide whether a generic should be approved and could aid in future policy-making, the agency maintains.

FDA adds the rule ultimately could help speed up the ANDA approval process, and likely would not have a large financial impact on generic drug firms.

Separately, FDA projects publishing an interim final rule in December requiring drug product labeling to include a toll-free number for adverse event reports. The action was stipulated in the Best Pharmaceuticals for Children Act, signed into law by President Bush in January (¹ 'The Tan Sheet' Jan. 14, 2002, p. 2).

The agency met its goal for issuing a labeling amendment to the pediculicide drug products final monograph, which appeared in the May 10 Federal Register (² Also see "Pyrethrum Pediculicide Labeling Revisions Would Provide More Detail – FDA" - Pink Sheet, 13 May, 2002., p. 6).

FDA's timetable of upcoming monograph actions is shorter than usual due to the agency's attempt to streamline the list. FDA included only monographs that were likely to be acted on within the next year; the antimicrobial and healthcare antiseptics products monographs were left out (see chart: " ³ FDA OTC Review Document Targeted Release Dates ").

According to the "unified agenda," the long-awaited dietary supplement GMP proposed rule is slated for September publication.

ANDA Bioequivalence Data Subject Of Upcoming FDA Proposed Rule

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