It was mutually agreed that rapid email responses would suffice, followed by official amendments to the NDA. Developers are also permitted to submit via the same rolling review process as the fast track designation. Priority review guarantees a shorter review cycle as the marketing application must be reviewed within six months as compared to a standard review, which can take as long as 10 months.
In addition, the FDA has been working collaboratively with the company helping to determine how much data would be needed to support its marketing application for a rare, orphan indication and recommending a rolling review so the preclinical and CMC data could be submitted while the Phase III clinical trial remained underway.
Real World Example A company was developing a new drug for hormone refractory metastatic prostate cancer. If no therapy exists for a serious condition, this demonstrates an obvious medical need.
The only available treatment option was with a chemotherapy docetaxel -containing treatment regimen. The development program would then need to demonstrate an unmet medical need still exists such as showing there is: It should be noted that rare diseases also qualify for expedited programs.
This agreement also allowed for batching of the amendments, which in turn helped to further accelerate the process.
Throughout the course of the trial, the company developer was able to secure frequent meetings with FDA officials, including several informal meetings with the anti-viral division — all of which allowed for accelerated drug development.
Developers can request a fast track designation at any point from the initial investigational new drug IND filing, but prior to the new drug application NDA filing.
Real World Example Another company developing a drug to treat a rare disease, for which no approved therapy exists, was granted both a breakthrough therapy designation and orphan drug designation.
Submitting a request prior can help ensure an organization receives the full benefits of this program. This designation was based on the preclinical and clinical data available at the time of the filing. In response to the need to hasten drug development and regulatory approvals, the FDA has provided developers with new tools to help expedite development programs and speed access to new products.
The benefits to breakthrough designation include intensive guidance on efficient drug development and commitment from the FDA to work together to expedite development. Obtaining a fast track designation provides actions to expedite development and review, most notably the rolling submission and review of different sections of the NDA prior to final submission of the clinical data.
Although the company did not have fast track designation, the FDA allowed the sponsor to submit the preclinical and CMC information while the Phase 3 study was ongoing.
Rethinking the Risk Equation in Biopharmaceutical Medicine. They even reviewed and provided CMC comments prior to the clinical data ever being submitted, thus demonstrating the power of the rolling review.
Communication and collaboration with FDA was key to this approval.
Here, we outline the key differentiators between each program and provide some real-world case examples from developers we have worked with to demonstrate how to successfully navigate these pathways to approval. The purpose of each is to help ensure therapies for serious conditions are approved and available to patients as soon as it is concluded the benefits justify their risks, while still preserving the standards for safety and efficacy:Accelerated Pathways of Approval RDC / –Framework for prioritization of registration, variations and clinical trial authorization Establishes the criterias for eligibility for the Priority Pathway: The product must meet at least one of the eligibility criteria (e.g.
Drug product for neglected disease; vaccine incorporated in the. “FDA’s accelerated approval pathway potentially promising drugs to receive marketing authorisation on the basis of surrogate measures that are easy to obtain, rather than clinically meaningful.
Accelerated Pathways Drug development traditionally involves long clinical trials and exposes thousands or tens-of-thousands of patients before health authorities can accept applications for market authorization. NEW PATHWAYS, AND OPPORTUNITIES, EVERYWHERE Accelerated Pathways (APs) for the development of new drugs in the U.S., Europe, and Japan – intended to bring needed and important new treatments to patients more quickly – have multiplied in recent years and have proven to present opportunities and benefits for patients and developers.
Feb 23, · The Food and Drug Administration has developed four distinct and successful approaches to making such drugs available as rapidly as possible: Priority Review; Breakthrough Therapy; Accelerated Approval; Fast Track; Because each of these approaches implies speed, there can be confusion about the specific meaning of each.
Throughout the course of the trial, the company developer was able to secure frequent meetings with FDA officials, including several informal meetings with the anti-viral division — all of which allowed for accelerated drug development.Download