post-marketing

Panel members who voted in support of dapagliflozin said they were also concerned with the potential cancer and other risks, but said that more information on those risks could only be discovered in large registries and post-marketing studies that could be set up after the product is approved.

FDA Panel Votes Against Diabetes Drug Jennifer Corbett Dooren 2011

Anne Erickson, a spokeswoman for Amylin Pharmaceuticals, makers of Byetta, said that "the conclusions of the study are in contrast to other nonclinical, clinical and adequately conducted post-marketing epidemiological studies."

Popular diabetes drugs may raise pancreatic cancer risk, study suggests 2011

According to a warning issued in 2004 by the drug manufacturer, Eli Lilly and Health Canada: There are clinical trial and post-marketing reports with SSRIs and other newer anti-depressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others.

Dr. Peter Breggin: Judge Agrees Prozac Could Have Made Teen a Killer Dr. Peter Breggin 2011

Now, if they're lucky and get market share before the FDA calls them on their ads, and the post-marketing adverse events don't kill the drug, then they can continue to sell as much as they can till the patent expires, at which point the generic manufacturers (which are increasingly becoming the initial makers of the drug) can step in like Walmart and clean up on the volume.

TBTAM on Healthcare Reform aka TBTAM 2009

The prescribing information for Juvisync will inform doctors of the possible blood-sugar side effect, and Merck is being required to conduct a post-marketing clinical trial comparing the glucose lowering ability of Januvia compared to Juvisync.

FDA Approves Merck Diabetes-Cholesterol Drug Jennifer Corbett Dooren 2011

According to a warning issued in 2004 by the drug manufacturer, Eli Lilly and Health Canada: There are clinical trial and post-marketing reports with SSRIs and other newer anti-depressants, in both pediatrics and adults, of severe agitation-type adverse events coupled with self-harm or harm to others.

Dr. Peter Breggin: Judge Agrees Prozac Could Have Made Teen a Killer Dr. Peter Breggin 2011

The CHMP considered that the new data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials used in the initial assessment of the medicine.

Dr. Sharma’s Obesity Notes » Blog Archive » Rimonabant Suspended in Europe 2008

A Phase IV trial, otherwise called post-marketing surveillance, monitors the safety and efficacy profile of the drug or device once regulatory permission is gran ...

Sunil Chacko: Innovations in Phase IV Clinical Trials for Change in Health Care 2009

A Phase IV trial, otherwise called post-marketing surveillance, monitors the safety and efficacy profile of the drug or device once regulatory permission is granted for sale via prescription or over the counter.

Sunil Chacko: Innovations in Phase IV Clinical Trials for Change in Health Care 2009

A Phase IV trial, otherwise called post-marketing surveillance, monitors the safety and efficacy profile of the drug or device once regulatory permission is gran ... digg

Sunil Chacko: Innovations in Phase IV Clinical Trials for Change in Health Care 2009