Upon receiving a Complete Response Letter (CRL) for their lead product to manage mild to moderate pain, a mid-sized specialty pharmaceutical company engaged Greenleaf Health to assist them in addressing the deficiencies cited in the CRL and developing a strategy for resubmitting the new drug application (NDA).
Greenleaf’s regulatory experts, in conjunction with a partner regulatory law firm, conducted a rigorous review of all relevant regulatory communications between the FDA and the client as well as selected modules of the NDA. Following the initial document review, the Greenleaf team suggested that the client initiate a formal dispute resolution request (FDRR), advising that their strategy focus on a revamped clinical data presentation and updated proposed labeling language. Over the next eight months, Greenleaf and our legal partners supported the client through the entire dispute resolution process. The Greenleaf team carefully reviewed and provided timely comments on all of the client’s written and oral communications with the FDA. Greenleaf also helped the client prepare for FDA meetings and held debrief sessions with the client after each interaction with the Agency.
The FDA granted the client’s appeal. Greenleaf provided further support in assembling the resubmission, which ultimately led to approval of the client’s lead product.