Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203 Compliance Policy Guide and Guidance for Industry: Prescription Drug Marketing Act Pedigree Requirements Questions and Answers; Notice of Availability

Zusammenfassung

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. 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.