
FDA Issues Guidance on Expedited Programs for Serious Conditions
FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.
FDA has finalized
The four programs are Fast-Track Designation, Breakthrough Therapy Designation, Accelerated Approval, and Priority Review Designation.
- Fast-Track Designation provides frequent discussions about a drug’s development program with FDA to ensure the collection of appropriate data to support approval.
- Accelerated Approval bases approval on an agreed surrogate marker instead of a clinical endpoint.
- Priority Review Designation reduces the drug application review time from 10 months to 6 months.
- Breakthrough Therapy Designation provides fast-track designation as well as FDA staff involvement in the drug development and review process.
In an
According to Woodcock, these expedited drug approval programs have impacted new drug approvals and were used to expedite novel drugs in 2013 with review times as short as 4.5 months. The Breakthrough Therapy Designation has resulted in 48 out of 186 designation requests being granted as of May 5, 2014. And, Woodcock states that 80 new products have been approved through the Accelerated Approval pathway since 1992, resulting in innovative cancer and HIV treatments.
“The Food and Drug Administration (FDA) is committed to doing our part to help bridge this gap. In this context, we have been actively scrutinizing, strengthening and streamlining our regulatory processes at various steps along the path from drug discovery to delivery—including the clinical development phase, the longest and most expensive period of drug development. As part of this effort, we have developed and successfully used a number of flexible and innovative approaches to expedite the development and review of drugs—to the benefit of millions of American patients,” says Woodcock in the blog post.
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