FDA is looking for input on distributed (“DM”) and point-of-care (“POC”) drug manufacturing. Typically, pharmaceutical companies have produced drugs at larger rooted facilities, but are designing technologies and practices to develop their products at smaller, mobile drug manufacturing sites. There are currently no FDA-approved drugs being manufactured using these new technologies.
The mobile locations, including at hospitals or clinics, have the potential to strengthen the drug supply chain. FDA has issued a discussion paper aimed at soliciting early input from industry to assist in developing a regulatory framework for DM and POC manufacturing.
The FDA is encouraging stakeholder to provide input at a public workshop on November 14-16, or to provide comments under docket number FDA-2022-N-2316. The deadline for comments is December 13, 2022.