FDA PDMA Pedigree Requirements: Compliance Policy Guide and Q&A Documents

November 15, 2006

FDA PDMA Pedigree Requirements: Compliance Policy Guide and Q&A Documents

The Food and Drug Administration (FDA) is announcing the availability of a final Compliance Policy Guide (CPG) 160.900 entitled "Prescription Drug Marketing Act - Pedigree Requirements under 21 CFR Part 203" (PDMA CPG). This CPG describes how the agency intends to prioritize its enforcement efforts in the first year after the December 1, 2006, effective date of 21 CFR Sec. 203.3(u) and 203.50. In addition, the FDA is announcing the availability of "Guidance for Industry: Prescription Drug Marketing Act (PDMA) Pedigree Requirements Questions and Answers" (PDMA Q&A). The PDMA Q&A guidance is issued in response to the many questions received regarding the Prescription Drug Marketing Act (PDMA) pedigree requirements. The two guidance documents explain FDA's current thinking on issues related to the pedigree requirements of the PDMA.

DATES: The effective date for the PDMA CPG is December 1, 2006. The PDMA CPG expires December 1, 2007. The PDMA Q&A guidance is effective November 15, 2006. Submit written or electronic comments on the PDMA Q&A guidance or the PDMA CPG at any time.

NOTE: For in-depth background information and details on public comments submission, please download the full Federal Register notice below.

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