FDA Re-Examining Citizen Petition Process To Speed Generic Approvals
Executive Summary
FDA is taking another look at its citizen petition review process in an attempt to expedite decisions on generic drug applications, Center for Drug Evaluation & Research Acting Director Steven Galson told the Generic Pharmaceutical Association's annual meeting Feb. 25 in Boca Raton, Fla
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The Senate Appropriations committee lauds FDA's citizen petition reform activities in the Agriculture spending bill report, and requests the agency provide a report on its citizen petition improvement efforts within 120 days of bill passage. The full committee reported the bill June 22. FDA's report should include "any need for additional funding," the committee states. FDA is examining its petition review process in an attempt to expedite generic drug approvals (1"The Pink Sheet" March 7, 2005, p. 34). In a May report, FDA informed Congress that "many of these citizen petitions might reasonably appear to have been filed in an attempt to delay approval of a generic version of a drug that is not yet subject to generic competition," the committee report states...
Senate appropriators like citizen petition activities
The Senate Appropriations committee lauds FDA's citizen petition reform activities in the Agriculture spending bill report, and requests the agency provide a report on its citizen petition improvement efforts within 120 days of bill passage. The full committee reported the bill June 22. FDA's report should include "any need for additional funding," the committee states. FDA is examining its petition review process in an attempt to expedite generic drug approvals (1"The Pink Sheet" March 7, 2005, p. 34). In a May report, FDA informed Congress that "many of these citizen petitions might reasonably appear to have been filed in an attempt to delay approval of a generic version of a drug that is not yet subject to generic competition," the committee report states...
FDA Report On Citizen Petition Impact On ANDAs Sought By Senate Panel
The Senate Appropriations Committee requests FDA report within 45 days on improvements to the citizen petition process as it relates to generic drug applications