FDA re­leas­es PDU­FA VI pro­gram re­port on com­bi­na­tion prod­ucts

A new in­de­pen­dent re­port on the FDA’s re­view prac­tices for com­bi­na­tion prod­ucts un­der the Pre­scrip­tion Drug User Fee Act (PDU­FA VI) gives the agency gen­er­al­ly pos­i­tive marks but finds room for re­fine­ments in com­mu­ni­ca­tion and tech­nol­o­gy to im­prove the pre-sub­mis­sion and re­view process.

The re­port, com­mis­sioned by FDA as part of its PDU­FA VI com­mit­ments, was con­duct­ed by East­ern Re­search Group and looked at FDA staff and spon­sor ex­pe­ri­ences with com­bi­na­tion prod­ucts re­views dur­ing the pre-re­quest for des­ig­na­tion (pre-RFD), RFD, in­ter-cen­ter con­sult re­quest (IC­CR) and ap­pli­ca­tion sub­mis­sion stages.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.