If the sponsor receives a letter stating that no agreement has been reached with the Agency, the sponsor may initiate the study without agreement, respond in writing to the FDA to address the non-convention letter without launching the study or request a meeting to discuss the non-convention letter. 2. BSUFA`s objectives were later updated in conjunction with the Biosimilar Users amendments of 2017. This guide is published in accordance with the FDA`s good guide Published Start Printed Page 16369Practices Regulation (21 CFR 10.115). The guidelines represent the FDA`s current thinking on the SPA. It does not create any rights for a person and is not mandatory for the FDA or the public. You can opt for an alternative approach if it complies with the provisions of the statutes and regulations in force. This guide is not subject to Executive Order 12866. Three types of protocols relating to PDUFA products are adapted to this specific evaluation of the protocol within the framework of the objectives of the PDUFA: 1) written agreement between the FDA and the proponent or the new design of the Phase III study will be communicated to the market at a later date, once it has been agreed with the FDA, and when the time comes , it will appear on “clinicaltrials.gov.” ImmuPharma`s licensing partner for Lupuzor™, Avion Pharmaceuticals LLC (“Airplane”), has submitted a special protocol review (“SPA”) to the U.S. Food and Drug Administration (“FDA”). Spa is a process by which sponsors agree with the FDA on the design and size of clinical trials, in order to adequately meet the scientific and regulatory requirements of a study that could support marketing authorization.
The previous Phase III clinical study of Lupuzor™ in SLE was also conducted as part of the ImmuPharma SPA. The verification period for an SPA application can be up to 45 days. While helping to present the types of new information, the FDA can earn significantly enough to get the removal of a SPA, the examples advice provided are formulated in such a way that their usefulness as clear and predictive guidelines is limited. In addition, the guidelines also mention “an evolving understanding of the design of the protocol”; Knowledge from ongoing clinical studies and the definition of data for similar product development programs” as additional scientific and medical innovations that may be subject to the withdrawal of spa studies. Without a more detailed and accurate description of what is considered a major scientific problem, the uncertainty associated with the SPA program will remain. The FOR FURTHER INFORMATION CONTACT section contains the name and phone number of someone in your agency who can answer questions about the document. It can list two or more people with whom it can contact different aspects of a document. The D`Amarin Vascepa SPA resignation controversy as well as the reported low probability of reaching consensus with the FDA could threaten to reduce the perceived value of such agreements. The FDA updated the original SPA guideline in May 2016 and noted concerns about the withdrawal of SPA by noting that less than 1% of the more than 1,000 SPA agreements adopted since the passage of the Food and Drug Modernization Act of 1997 (FDAMA) have been repealed. The updated guide also specifies the FDA`s definition for “an essential scientific subject, essential for determining safety or efficacy,” for which the FDA is able to revoke an SPA agreement.