IDIQ for CDER GDUFA research program for brand name and/or generic pharmaceuticals to include small molecule and peptide therapeutics.

The Food and Drug Administration's Center for Drug Evaluation and Research (CDER) is seeking a single award indefinite delivery, indefinite quantity (IDIQ) contract to support the Generic Drug User Fee Amendments (GDUFA) research program. This contract will require a pharmaceutical manufacturer or supplier to provide a broad range of approximately 75 types of pharmaceuticals, including both brand name and generic drugs, covering small molecule and peptide therapeutics. The contract aims to ensure consistent and suitable supplies of these pharmaceuticals to facilitate research initiatives under the GDUFA program. The contract is classified under NAICS code 325412, which pertains to pharmaceutical preparation manufacturing. The opportunity is forecasted and open for engagement, with the point of contact and contracting officer listed as Nick Sartain from the FDA. The precise location of performance is unspecified, reflecting the broad national scope typical of such federal contracts. This contract will enhance CDER's capabilities in advancing drug evaluation and development processes by securing critical pharmaceutical products needed for research activities.