FDA CRL - PharmaEssentia Corporation

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to PharmaEssentia Corporation for its Biologics License Application (BLA) 761166 for product P1101, indicating the application cannot be approved in its current form. The primary deficiencies identified involved human factors and facility inspections. The FDA determined that the proposed product design and user interface, based on human factors validation study data, do not adequately support safe and effective use. PharmaEssentia is required to implement FDA protocol recommendations, consider design and labeling modifications, and submit results from a new human factors validation study.

Additionally, required inspections of PharmaEssentia Corporation’s manufacturing facilities in Taichung and Taipei, Taiwan (FEI 2000012832 and FEI 3005182038) could not be conducted during the current review cycle due to travel restrictions. These inspections are crucial to assess compliance with Current Good Manufacturing Practices, and approval is contingent upon their satisfactory completion.

Other requirements for a complete response include providing a comprehensive safety update, incorporating new nonclinical and clinical data, and addressing recommendations regarding bioburden and sterility test method suitability by providing data from three batches. The proprietary name, Besremi, was found acceptable but must be resubmitted with the corrected application. PharmaEssentia Corporation must address all deficiencies and resubmit the application within one year under 21 CFR 601.3(b).