CPC Comments on FDA’s Identification of Manufacturing Establishments in CBER/CDER Applications Guidance

On January 29, 2020, the CPC submitted comments on FDA’s “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers Guidance for Industry,” which was issued on October 22, 2019. While the CPC appreciates the value of this Guidance in providing FDA’s expectations for identification of manufacturing establishments to facilitate FDA’s review and inspection activities, the CPC has some concerns and suggestions for improvement. For example, we recommend that FDA: (1) limit the scope of sites listed on FDA Form 356h and in Module 3 to those involved in the disposition of commercial product; (2) limit inclusion of FEI number, name and title of onsite contact person, contact details, and confirmation of inspection readiness to Form 356h in accordance with least burdensome approach; and (3) clarify that facilities manufacturing device components/sub-assemblies which are separately provided to combination product manufacturers for further modification/assembly/packaging with the drug constituent part are considered device component manufacturing facilities and should not be listed on Form 356h or in Module 3.