postmarketing

The FDA and companies routinely revise drug labels when there are new clinical data or side-effects seen in so-called "postmarketing event reports," or side-effects seen in patients after the drug hits the market.

FDA: Avastin Could Affect Fertility in Women Jennifer Corbett Dooren 2011

Another FDA letter to the company said that "postmarketing cases of new onset and worsening heart failure have been reported" with Multaq.

FDA Reviews Heart-Rhythm Drug Thomas M. Burton 2011

In a statement, Roche's Genentech unit, which markets Avastin in the U.S., said it "takes patient safety very seriously and consistently reports new safety information about our medicines, collected through clinical trials and in the postmarketing setting" to the FDA.

FDA: Avastin Could Affect Fertility in Women Jennifer Corbett Dooren 2011

They wrote, “The design and reporting of safety outcomes in MMR vaccine studies, both pre and postmarketing is largely inadequate” [134].

On Thursday, the Legg report will be published along with... 2009

They wrote, “The design and reporting of safety outcomes in MMR vaccine studies, both pre and postmarketing is largely inadequate” [134].

The witch-hunt against Andrew Wakefield 2009

They wrote, “The design and reporting of safety outcomes in MMR vaccine studies, both pre and postmarketing is largely inadequate” [134].

The witch-hunt against Andrew Wakefield 2009

It's hardly a surprise that many members of Congress avert their eyes when your own safety experts complain that unsafe drugs are being rushed to market while postmarketing safety studies -- so necessary to ensure the public health - are delayed or simply ignored.

Jeanne Lenzer and Shannon Brownlee: A New Year's Resolution for the FDA: Kick the Drug (Company) Addiction 2009

Instead, money should be appropriated by Congress from general revenues to fund both drug approval and postmarketing surveillance.

Jeanne Lenzer and Shannon Brownlee: A New Year's Resolution for the FDA: Kick the Drug (Company) Addiction 2009

You see, even though "Mr. Grassley did some good after the Vioxx episode, by focusing on the woeful manner in which postmarketing drug safety is managed and regulated by the FDA," writes Thornton, who the Journal identifies as a former medical officer in the Office of Oncology Products at the FDA who "volunteers as president of the Sarcoma Foundation of America," the Senator "and his staff should have kept their eyes on the ball."

Former FDA Officer Worries New Rules Will Curb Industry Profiteering 2008

I am releasing a report today which reveals that of the 91 postmarketing studies required by the FDA, 42 studies have not been completed and half of the unfinished studies have not even started.

Ed Markey: What Are They Waiting For? 2008