OVARIAN CANCER and US: drug approvals

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Showing posts with label drug approvals. Show all posts
Showing posts with label drug approvals. Show all posts

Thursday, May 17, 2012

press release: In drug-approval race, US FDA ahead of Canada, Europe (range: 322-393 days)



In drug-approval race, US FDA ahead of Canada, Europe

Public release date: 16-May-2012

The U.S. Food and Drug Administration (FDA) generally approves drug therapies faster and earlier than its counterparts in Canada and Europe, according to a new study by Yale School of Medicine researchers. The study counters perceptions that the drug approval process in the United States is especially slow.

Led by second-year medical student Nicholas Downing and senior author Joseph S. Ross, M.D., assistant professor of internal medicine at Yale School of Medicine, the study will be published May 16 online by the New England Journal of Medicine.

Regulatory review represents the final step in the process of bringing new medical technologies from the lab to the bedside. Efficient regulatory review processes may enable patients to get access to promising new therapies sooner, while ensuring drug safety.
"The perception that the FDA is too slow implies that sick patients are waiting unnecessarily for regulators to complete their review of new drug applications," said Downing, who decided to conduct the study because there have been no recent comparisons of the FDA's regulatory review speed with those of regulating agencies in other countries.
Downing, Ross, and colleagues reviewed drug approval decisions of the FDA, the Canadian drug regulator, Health Canada, and the European Medicines Agency (EMA) between 2001 and 2010. They studied each regulator's database of drug approvals to identify novel therapeutics as well as the timing of key regulatory events, allowing regulatory review speed to be calculated. Canada and Europe were chosen as a comparison because they face similar pressures to approve new drugs quickly while ensuring they do not put patients at risk.

The team found that the median total time to review was 322 days at FDA, 366 days at EMA and 393 days at Health Canada.

"Among the subsample of drugs approved for all three regulators, the FDA's reviews were over three months faster than those of the EMA or Health Canada," said Downing. "The total review time at the FDA was faster than EMA, despite the FDA's far higher proportion of applications requiring multiple regulatory reviews."

Downing added that most new drug therapies were first approved for use in the U.S. "Examining novel drugs approved in multiple markets, we found that 64% of medicines approved in both the U.S. and in Europe were approved for U.S. patients first, and 86% of medicines approved in both the U.S. and Canada were also approved first in the U.S." he said.
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Other authors on the study included Jenerius A. Aminawung, Nilay D. Shah, Joel B. Braunstein, and Harlan M. Krumholz.
The study was funded by the Pew Charitable Trusts.
Citation: New England Journal of Medicine, doi: 10.1056/NEJMoa1200223

Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies — NEJM (U.S./Canada/Europe) note references to safety



Regulatory Review of Novel Therapeutics — Comparison of Three Regulatory Agencies — NEJM

"In conclusion, we found that among novel (new) therapeutics approved between 2001 and 2010, the FDA reviewed applications more quickly, on average, than did the EMA and Health Canada, and the vast majority of these novel therapeutics were first approved for use in the United States. Our findings contradict recent criticisms of the speed of review by the FDA and lead to questions about whether the speed of the review process is justified as an emphasis for PDUFA V, particularly since the FDA continues to outpace its European and Canadian peers."