💉FDA Notice on DPD Deficiency and Fluoropyrimidine Drugs
Dihydropyrimidine Dehydrogenase Deficiency and the Use of Fluoropyrimidine Chemotherapy Drugs; Establishment of a Public Docket; Request for Comments
Summary
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to solicit public comment for information on dihydropyrimidine dehydrogenase (DPD) deficiency and the use of fluorouracil and capecitabine (both fluoropyrimidine chemotherapy drugs). The purposes of the docket establishment are to foster Agency transparency and to solicit input on the currently available information on DPD deficiency and the use of fluorouracil and capecitabine.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
The FDA's establishment of a public docket regarding DPD deficiency and fluoropyrimidine chemotherapy drugs suggests a need for healthcare providers to consider genetic testing before treatment. This may impact compliance and regulatory requirements for oncology practices and pharmaceutical companies, as they may need to adapt dosing protocols or submit new testing products.