Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry: Fast Track Drug Development Programs_Designation, Development, and Application Review (03AUG99)
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Prepublication document
Supporting Statement

Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Industry: Designation, Development, and Application Review for Products in Fast-Track Drug Development Programs. (06MAY99) Click here for txt or pdf

Draft Guidance for Industry on Accelerated Approval Products: Submission of Promotional Materials; Availability. (26MAR99)
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Guidance . Click here for pdf

Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry: Designation, Development, and Application Review for Products in Fast-track Drug Development Programs. (27JAN99)
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Agency Information Collection Activities; Announcement of OMB Approval; Guidance for Industry: Fast Track Drug Development Programs--Designation, Development, and Application Review. (04JAN99)
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