Posts tagged with: "fda"
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3 Feb 2014, 11:33 am
FDA Will Investigate Approved Testosterone Therapies for Heart Link The Food and Drug Administration (FDA) issued a statement on Friday, January 31st, that the agency will investigate reported risks for heart attack and stroke associated with testosterone therapy. [read post]
29 Apr 2007, 11:22 am
The FDA is alerting health care professionals and consumers to the availability of audio broadcasts that provide emerging drug safety information.The service is part of the agency's effort to speed up communications concerning the safety of marketed medications when unexpected adverse events are reported to FDA. [read post]
13 Jan 2009, 11:03 pm
The FDA has issued a final "Guidance for Industry" which provides "the agency's views on the distribution of medical journal articles and scientific or medical reference publications that discuss unapproved new uses" for FDA-approved drugs and medical devices. [read post]
6 Jan 2010, 12:00 am
According to the report, from 2000-2007 the FDA approved 78 cardiovascular devices with relatively little evidence. [read post]
1 Jan 2007, 2:18 pm
In a Fall 2006 release, the FDA urged consumers not to buy drugs on line from Canadian pharmacies. [read post]
24 Feb 2010, 8:13 pm
The announcement this week only confirms that the FDA is reviewing data and has no new conclusions. [read post]
10 Jun 2024, 9:15 pm
The FDA and CDC do not rest in protecting us. [read post]
18 Sep 2015, 8:29 am
Recalls can be made by the manufacturer or by the FDA. [read post]
16 Jun 2015, 2:57 pm
FDA-2013-N-1317] Final Determination Regarding Partially Hydrogenated Oils AGENCY: Food and Drug Administration, HHS. [read post]
26 Apr 2007, 6:20 am
The FDA's first three pro-preemption amicus briefs were filed in 2000 by the Clinton administration FDA and Justice Department. [read post]
30 Oct 2006, 6:29 pm
FDA attacks continue unabated over failure to adequately measure drug risks prior to new drug approval.... [read post]
28 Feb 2008, 10:07 am
Less than three weeks ago (it seems a lot longer) we posted about the FDA's position that expert witnesses shouldn't be allowed to opine on the meaning of FDA regulations during trial. [read post]
28 Jul 2012, 11:42 am
” On top of that, companies had to deal with the blizzard of new FDA enforcement actions Why should the FDA care? [read post]
4 Apr 2012, 1:41 pm
FDA, 2012 U.S. [read post]
24 Jun 2011, 4:53 am
The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk. [read post]
2 May 2007, 4:29 pm
Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in... [read post]
7 Aug 2006, 10:32 am
"FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs).... [read post]
8 Jan 2018, 9:00 am
FDA does not require that specific tests be taken or met. [read post]
5 Aug 2022, 10:00 am
FDA must demonstrate similar leadership and commitment to global health by reforming its outdated, restrictive practices on information sharing. [read post]
17 Apr 2020, 8:00 am
The report summarizes the evaluation of FDA’s proposed capacity planning adjustment methodology to calculate the annual fees for human drugs and biosimilar biologics under the FDA Reauthorization Act of 2017. [read post]
