Discussion Paper: Distributed Manufacturing and Point-of-Care Manufacturing of Drugs; Request for Information and Comments
FDA | October 14, 2022
This discussion paper presented areas associated with DM and POC manufacturing that FDA has identified for consideration as FDA evaluates existing risk-based regulatory framework as it applies to these technologies. CDER scientific and policy experts identified these areas from a comprehensive analysis of existing regulatory requirements applicable to the approval of drugs manufactured using DM and POC technologies. This analysis included a review of applicable statutory provisions, regulations, and guidance related to quality assessment and inspections to determine whether an application presenting an advanced manufacturing technology can fit within our current regulatory framework.
The areas of consideration in this discussion paper are those for which FDA wanted public feedback. The Food and Drug Administration (FDA or Agency) publication of the discussion paper provided information for stakeholders and soliciting public comments on specific areas of emerging and advanced manufacturing technologies. The discussion paper presents areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with distributed manufacturing (DM) and point-of-care (POC) manufacturing for drugs, including biological products regulated by CDER and the Center for Biologics Evaluation and Research (CBER). FDA recognizes that regulatory policies and programs may need to evolve to enable the timely adoption of these technologies. The discussion paper includes a series of questions for each technology to stimulate feedback from the public. Submissions were to be submitted by December 13, 2022.
The areas of consideration presented in this discussion paper focus on products that would be marketed under an New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA). CDER is releasing this discussion paper to share information with, and gather input from, the public on DM and POC manufacturing. A series of discussion questions after each technology is included to stimulate feedback. This feedback will help inform CDER’s evaluation of our existing regulatory framework as it applies to advanced manufacturing technologies to ensure production of quality drugs for U.S. patients. While the initial analysis focused on products regulated by CDER, FDA’s Center for Biologics Evaluation and Research (CBER) also expects the development of advanced manufacturing technologies associated with DM and POC manufacturing for products that it regulates. As such, we invite feedback on the discussion questions related to products regulated by CDER and CBER.
The submission by Blood Centers of America to the FDA can be viewed and downloaded here: Blood Centers of America Discussion Paper Comments Final (submitted)
About Blood Centers of America
Blood Centers of America (BCA) is the largest blood supply network in the U.S., uniquely positioned to sustain, mobilize and advocate for the nation’s blood supply. Our 60+ independent community blood centers collect and distribute more than 5.4 million blood units annually, or 50% of the nation’s blood supply. We are committed to delivering reliable service and providing high-quality blood products for patients in the communities we serve.