post-approval

It was approved in 1997 to prevent epileptic seizures on the condition that the company that Cyberonics carry out a post-approval study to examine the safety of the device.

Is the FDA doing its job? Rob Stein 2010

In fact, in 2005 the FDA itself evaluated its post-approval studies and found more than one-fifth "couldn't be evaluated for quality because there was no record at the FDA showing they had ever been conducted," according to the report.

Is the FDA doing its job? Rob Stein 2010

The FDA said it wants to find ways to improve post-approval safety studies and to identify new approaches to mandated studies and surveillance of silicone implants that are likely to yield valuable information on their safety and performance.

FDA questions studies of breast implant safety 2011

Weakening data exclusivity rules would put a rapid stop to such post-approval research--and much of the pre-approval research too.

Enabling The Next Biomedical Revolution Sally C. Pipes 2011

Generally, half of post-approval studies involving fast-tracked drugs go on to validate initial therapeutic claims, the remainder either fail to show favorable risk/benefit profiles or the studies are not completed.

Haste and Waste and Fast Approval 2011

The company also said it has invested or committed more than $250 million to bring Makena to market including funding post-approval studies.

FDA Stance Is Setback for K-V Pharmaceutical Jennifer Corbett Dooren 2011

The safety findings were based on preliminary data from six ongoing post-approval studies conducted by Allergan and Mentor, the only two companies that make silicone implants available in the United States.

FDA questions studies of breast implant safety 2011

Biologic companies perform post-approval research not only to improve effectiveness, but also to find "new indications," allowing the drug to be used to treat a variant of the same condition or even an entirely new condition.

Enabling The Next Biomedical Revolution Sally C. Pipes 2011

What seems to be happening is that Dendreon has moved from pre-approval exuberance to post-approval malaise much faster than anybody would have expected.

June's Biotech Busts And Breakthroughs 2010

What seems to be happening is that Dendreon has moved from pre-approval exuberance to post-approval malaise much faster than anybody would have expected.

June's Biotech Busts And Breakthroughs 2010