FDA Approval

4 mins 17/06/20
Author name: Terri Nataline

Understanding the Path to Expedited FDA Approval

The medical product development journey can be long and the investment is large. The path to market – and ultimately to the patient – depends on timing, which includes the speed with which your product can gain approval from the Food and Drug Administration. At Metrics Contract Services, we can help you sort through the expedited review process and select the proper regulatory path.

The FDA has several programs that can offer opportunities for expedited review:

Fast Track Designation: A product may qualify for Fast Track if it is intended to treat a serious disease, has the potential to meet an unmet medical need, or may be designated as a qualified infectious disease product. Fast track can be requested at any time. One advantage is better access to the FDA, including more communications to facilitate efficient product development, data collection, and clinical trial design. Certain products may be eligible for Accelerated Approval, Priority Review or have the option for Rolling Review, which allows sponsors to submit sections of their marketing applications for review as they are completed rather than waiting until all application sections are completed before the review can begin.

Breakthrough Designation: This designation targets products intended to treat serious medical conditions that also have potential to show clinically significant improvement over existing therapies. Breakthrough Designation should be requested no later than the end-of-phase 2 meeting. Products granted the designation receive FDA guidance on efficient drug development and review.

Accelerated Approval: This approval allows drugs that are both intended for treating serious medical condition and fill an unmet medical need to be approved based on an intermediate endpoint rather than requiring pre-approval evidence of actual clinical benefit. Accelerated Approval should be discussed as early in development as is feasible because the designation allows promising drugs to get to market considerably faster than they would otherwise.

Priority Review Designation: Therapies likely to provide significant improvements in the safety or effectiveness of the treatment, diagnosis or the prevention of a serious medical condition fit this designation. Priority Review also is for those designated as a qualified infectious disease product, those submitted with a priority review voucher, or those for which the submission is a supplement proposing a labeling change based upon the results of a pediatric study under Section 505A of the FD&C Act. The designation may be requested by the sponsor, and it indicates that FDA intends to take action on an application within 6 months of filing, compared to the 10-month review clock for a standard submission. Priority Review designation can be critical for products in competitive fields where first-to-market therapies often have significant advantages.

These FDA programs may expedite product development and approval. We help clients understand what these programs are, when action needs to be taken, and why they are advantageous in moving a product to market faster and at lower cost. As your commercial arm, we will work with you to determine the appropriate regulatory pathway and compile all the relevant data required for a successful submission. We ensure that you clearly communicate to the FDA how your product meets the regulatory requirements for approval. Your submission will be complete, consistent, and adhere to the necessary standards.

At Metrics Contract Services, patients are our priority just like they are yours. We want them to have timely access to affordable drug products and therapies that improve their health and lives. Navigating FDA regulations is routine territory for us, and we have a proven technical record on execution. The process is seamless once you’re involved with us. In the long journey from concept to commercialization, we are here to help you across the finish line.

Related Content