Advisory Committee Dispute Resolution Requests To Be Decided In 30 Days
This article was originally published in The Tan Sheet
Executive Summary
Appeals for dispute resolution between a product sponsor and FDA, including requests for advisory committees to hear disputes, will be approved or denied by the agency within 30 days for user fee products, a March 19 draft guidance indicates.
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Dispute resolution
FDA announces availability of final guidance, "Formal Dispute Resolution: Appeals Above the Division Level," in the Federal Register March 7. The guidance provides procedures that will be adopted by the Center for Drug Evaluation & Research for resolving scientific and procedural disputes that cannot be settled at the division level. The document, describing methods for formally appealing such disputes to the office or center level, bears few changes from a draft version published in March (1"The Tan Sheet" March 22, 1999, p. 18)
Dispute resolution
FDA announces availability of final guidance, "Formal Dispute Resolution: Appeals Above the Division Level," in the Federal Register March 7. The guidance provides procedures that will be adopted by the Center for Drug Evaluation & Research for resolving scientific and procedural disputes that cannot be settled at the division level. The document, describing methods for formally appealing such disputes to the office or center level, bears few changes from a draft version published in March (1"The Tan Sheet" March 22, 1999, p. 18)
Dispute resolution
FDA announces availability of final guidance, "Formal Dispute Resolution: Appeals Above the Division Level," in the Federal Register March 7. The guidance provides procedures that will be adopted by the Center for Drug Evaluation & Research for resolving scientific and procedural disputes that cannot be settled at the division level. The document, describing methods for formally appealing such disputes to the office or center level, bears few changes from a draft version published in March (1"The Tan Sheet" March 22, 1999, p. 18)