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FDA Report: Early and Effective Communication Key to First-Cycle Approval

Communication with FDA Key to Early NDA, BLA Approval

The difference between getting your NDA or BLA approved by the FDA during the first cycle of product review and getting it approved much later may very well lie in how early and how effective you communicate with the agency.

This is one of the major findings of a recent report titled ?Independent Evaluation of FDA's First Cycle Review Performance: Retrospective Analysis.? The report analyzed factors affecting the first cycle of review of new drugs (new drug application or NDA) and biologics (biologic license application or BLA). It showed that 52 percent of companies that met with the FDA at the end of Phase II trials received approval during the first cycle. Only 29 percent of sponsors that did not consult the FDA during this phase gained approval during the first cycle. It's even better to meet with the FDA prior to submission. The report showed that out of 58 products with pre-submission meetings, almost half received first-cycle approval.

?FDA reviewer team members agree that early on-going dialogue with sponsors is the most important factor in identifying issues and potentially providing an opportunity for timely resolution, ideally before first action is taken,? according to the report.

In Fiscal 2005, the FDA received over 2,400 requests for formal meetings with companies on products covered by the Prescription Drug User Fee Act that are in development. The independent report, conducted by Booz Allen Hamilton, shows that increased communication with the FDA often results in a more informed and efficient drug development process, especially for products representing a major innovation and have significant public health impact.

The study was comprised of all new molecular entity applications (NMEs for NDAs) and BLAs submitted between fiscal year 2002 and 2004 that had reached first action by Dec. 1, 2004. There were 77 in total, consisting of 14 BLAs and 63 NDAs. ?Drivers of multi-cycle reviews were found to include product characteristics, sponsor characteristics, quality of the design and execution of the drug development program, variations in review processes, and development of post-marketing commitments,? according to the report.

The more experience a sponsor has with the FDA approval process, the better its chance to get first-cycle approval. The first-cycle approval rate for sponsors that had drugs previously approved was 51 percent compared to only 30 percent for those with no prior approved drugs. ?Unfamiliarity with FDA regulations and the drug application process is a key problem for inexperienced sponsors and results in poor quality submissions,? said the report.

Report Recommendations

Among the report's recommendations are:

  • The FDA should play a more proactive role throughout the development process to better identify and communicate issues and potential deficiencies earlier in the review process.

  • The FDA should follow up with sponsors after ?milestone? meetings to ensure the sponsor has adequately addressed issues identified.

  • Inexperienced sponsors may need to complement their teams with experienced regulatory consultants or clinical research organizations. They can also benefit from engaging in early and open dialogue employing FDA-preferred methods (e.g., appropriate forms and correct submission procedures) and developing processes to respond to FDA requests quickly.

  • The FDA can target inexperienced sponsors with workshops and updated and streamlined guidance portfolios, as well as improving the utility of its Web site that includes sections for these sponsors.

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FDA Link

  • FDA's First-Cycle Review Performance Report

Additional Article