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# Stakeholder SPA Guidance Suggestions
- URL: https://www.fdaweb.com/stakeholder-spa-guidance-suggestions/
- Published: 2016-07-21T12:00:00.000Z
- Updated: 2026-09-14T21:16:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136246

The Generic Pharmaceutical Association (GPhA) says that special protocol assessments (SPAs) are an important mechanism for developing biosimilars as they allow sponsors to engage with FDA and discuss the adequacy and acceptability of a proposed study design. [Commenting](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-D-1174-0012&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) on the agency’s draft guidance on SPAs, the association says it is concerned about FDA’s requirement that sponsors submit the SPA to an existing IND as this will require additional resources.

“As outlined in the draft guidance,” GPhA says, “sponsors without an active IND would be required to request a pre-IND number, request and attend a pre-IND meeting, open an IND, and then finally submit the SPA to the open IND.” The association says that under the biosimilars user fee agreement goals letter, a protocol may qualify for a SPA following a biosimilar product development meeting, Type 2 or Type 3 meeting. It says that requiring an open IND will effectively limit the ability of sponsors to submit SPAs, particularly for biosimilars, because Phase 2 studies are not conducted and Phase 1 PK/PD studies are typically conducted at one study site, and this site may be located outside of the U.S. where an IND is not required to be opened.

GPhA contends that a biosimilar product development Type 2 or Type 3 meeting will give the agency the necessary background to provide feedback on a biosimilar confirmatory efficacy and safety study.

The association also includes technical comments.

The Biotechnology Innovation Organization (BIO) [says](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-D-1174-0013&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) that while the draft guidance is helpful in describing FDA’s processes, the organization believes that the final guidance should place more emphasis on, and describe opportunities for, less formal modes of communication such as telephone or e-mail to allow for timely resolution of any areas of disagreement throughout the SPA process.

BIO also says it believes that implementation and consistent application of the guidance’s final version offers an opportunity to focus on the importance of cross-division and within-division consistency in SPA processes. “Moreover,” it adds, “the draft guidance and process, in general, would benefit from development of assessment process tools, such as checklists, manual of policies and procedures, and standard operating procedures, that are likely to promote predictability of outcomes.”

Technical comments also were submitted by BIO.