Accelerated Approval

Accelerated Approval

A regulatory mechanism developed by the US FDA to make new drug products available for serious or life threatening diseases when they appear to provide a benefit over available therapy—or when there is no effective treatment.
References in periodicals archive ?
This indication is approved under the FDA s accelerated approval process based on tumour response rate and duration of response (DoR).
Decision Follows Pre-NDA Meeting with the FDA to Request Accelerated Approval for Patients with Myelofibrosis and Low Platelet Counts -
Accelerated approval: The accelerated approval process was also implemented to shorten the approval time by permitting the use of surrogate end-points in clinical trials to reasonably predict that the new medication will be effective.
No formal votes were taken, but most members of an FDA advisory panel are backing agency intentions to tighten the accelerated approval process for oncology drugs.
The FDA gave Intelence preliminary approval in January 2008 under its accelerated approval program, which allowed J&J to market the drug.
This report provides information on (1) all drug applications approved based on surrogate endpoints in FDA's accelerated approval process, (2) a subset of applications for potentially innovative drugs approved based on surrogate endpoints under FDA's traditional process, and (3) FDA's oversight of postmarketing studies.
In November 2004, the FDA granted accelerated approval of Tysabri (natalizumab) for treatment of relapsing forms of MS, creating a new treatment option.
For new vaccines, they describe defined pathways for both traditional and accelerated approval approaches.
Truvada was given accelerated approval (which means that Gilead must complete additional work) because approval was based in part on clinical trials of Viread with 3TC--a drug similar to FTC but not the same.
Among drugs granted accelerated approval half of the studies have been completed and 28% have not begun.
The FDA says it reviewed Millennium's application under its accelerated approval program and approved the drug for use in just 4 months.
Full browser ?