The Food and Drug Administration released a report Thursday containing proposals for reauthorization of the Generic Drug User Fee Act that would accelerate the agency's drug approval process.
Here are four things to know.
1. The GDUFA, enacted in 2012, reshaped the FDA's generic drug program by authorizing funds for the agency to hire additional reviewers, modernizing the view of generic drug applications and expanding facility inspection capabilities, among other improvements.
2. Congress, which must reauthorize the funds for this program in the fall, plans to incorporate certain amendments to the legislation to further speed up the agency's approval process.
3. While the FDA originally had 10 months to review drugs with a priority status, Congress wants to drop that number down to eight months.
4. The reauthorized bill would also establish a pre-abbreviated new drug application program to help clarify regulatory expectations for drug companies early in the development process, according to the report.
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