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Review.pdf

FDA-Review-of-AA-in-JAMA-2018.pdf

🔗 Source: ffj-online.org

📊 Size: 329 KB

👤 Author: American Medical Association

⬇️ Downloads: 480

Summary

The US Food and Drug Administration (FDA) has an accelerated approval (AA) program for drugs and biologics that treat serious or life-threatening conditions, which was introduced in 1992. To qualify for AA, drugs must demonstrate an effect on an endpoint that is reasonably likely to predict clinical benefit. Between 1992 and 2017, the FDA granted AA to 64 malignant hematology and oncology products for 93 new indications, with 53 being new molecular entities. The most common endpoint used for AA was response rate (87%), followed by time-to-event endpoints (9%) and disease-free survival (4%). Single-arm trial designs were used in 72% of initial AA indications. Of the 93 AAs, 55% have fulfilled their postmarketing requirement and verified benefit, while 40% have not yet completed confirmatory trials, and 5% have been withdrawn from the market.

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Description

The US Food and Drug Administration (FDA) has an accelerated approval (AA) program for drugs and biologics that treat serious or life-threatening conditions,...

Technical Information

File Format: PDF
File Size: 329 KB
Pages: 8
Language: EN
Author: American Medical Association
Total Downloads: 480
Last Updated: 2 weeks ago

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