Intercenter Review Considerations In Co Development

Overcoming potential regulatory barriers to speed up introduction of innovative technologies and products, while ensuring their safety and effectiveness, is a major challenge. Co-development, to be most efficient, requires coordination and harmonization between FDA reviewing centers. The success of this coordination in part depends on the ability of all stakeholders to foster an increase in the dialogue between the FDA and industry and the ability of the FDA to engage sponsors in collaborative discussion early in the process as science develops.

Co-developed products that would be used together may or may not be combination products as defined in 21 CFR 3.2(e).1 FDA anticipates that many therapeutic drug and diagnostic test products will be marketed separately. For the purposes of this document, co-development refers to products that raise development issues that affect both the drug therapy and the diagnostic test, regardless of their regulatory status as a combination product or as a noncombination product. For example, when co- developed products are considered together, unique questions may arise that would not exist for either product alone. Scientific or technological issues for one product alone may be minimal, but they may have substantial implications for the other product. Also, postapproval changes in one may affect the safety and effectiveness of the other. The FDA has recently established the Office of Combination Products (OCP)2 to work with sponsors and FDA work groups to ensure that proper regulatory tools are applied to products used in combination and to assist in addressing problems that joint reviews may encounter.

If the diagnostic becomes integral to approval of the drug, diagnostic approval is needed in parallel with the drug. FDA review centers (CDER and CDRH) are willing to work with single sponsors or collaborating sponsors

(drug-diagnostics companies) to coordinate review processes and have in the past had conjoint teams, tandem panel meetings, and same-day approval of linked products. If the diagnostic has broad use not specifically linked to the drug or if the drug has use not specifically linked to the diagnostic, approvals would follow usual CDER or CDRH procedures and timelines.

In some cases, development of a diagnostic may follow development of a drug and be used to refine or improve the safety or effectiveness profile of the drug. CDER and CDRH will work collaboratively with OCP to determine best practices for addressing these situations in a timely manner.

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