New safety information for Invirase
The U.S. Food and Drug Administration announced that new safety information has been added to the label for the HIV antiviral drug Invirase (saquinavir).…
News
New warning added for gonadotropin-releasing hormone agonists
The U.S. Food and Drug Administration has asked manufacturers to add new labeling warnings for gonadotropin-releasing hormone (GnRH) agonists, mostly used to treat men…
Some fentanyl transdermal patches recalled
The U.S. Food and Drug Administration announced that Actavis Inc. has recalled 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches from wholesale…
Abbott withdraws Meridia from market
On Oct. 8, Abbott Laboratories voluntarily withdrew its weight loss drug Meridia (sibutramine) from the market in response to a request from the U.S.…
How to revive the FDA
The Oct. 6 New England Journal of Medicine includes a perspective on how to “revive” the U.S. Food and Drug Administration. Read it here.
Amgen, FDA announce voluntary recall of Epogen and Procrit
On Sept. 24, Amgen and the U.S. Food and Drug Administration announced that Amgen is voluntarily recalling certain lots of Epogen and Procrit (Epoetin…
Hospira infusers recalled
On Sept. 10, the U.S. Food and Drug Administration announced the recall of the Hospira Symbiq One-Channel and Two-Channel Infusers because of the potential…
Free online course on FDA drug regulation
Access “The Past, Present, and Future of FDA Human Drug Regulation,” a free educational program from the U.S. Food and Drug Administration is available…
Engage Introducer recalled
On Aug. 13, the U.S. Food and Drug Administration (FDA) announced the recall of 6 French Engage Introducers manufactured between April 27 and June…
FDA posting postmarketing drug safety evaluations
You can access U.S. Food and Drug Administration (FDA) postings on postmarketing drug safety evaluations online. For more information, click here.
The Avandia saga
Read an interesting editorial about Avandia here. A U.S. Food and Drug Administration panel recommended keeping the drug on the market, but increasing warnings…
Avastin may lose metastatic breast cancer indication
An U.S. Food and Drug Administration (FDA)-advisory panel has voted to strip Avastin’s indication for metastatic breast cancer because the drug is not effective…
New safety information for Invirase
The U.S. Food and Drug Administration announced that new safety information has been added to the label for the HIV antiviral drug…
New warning added for gonadotropin-releasing hormone agonists
The U.S. Food and Drug Administration has asked manufacturers to add new labeling warnings for gonadotropin-releasing hormone (GnRH) agonists, mostly used to…
Some fentanyl transdermal patches recalled
The U.S. Food and Drug Administration announced that Actavis Inc. has recalled 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches…
Abbott withdraws Meridia from market
On Oct. 8, Abbott Laboratories voluntarily withdrew its weight loss drug Meridia (sibutramine) from the market in response to a request from…
How to revive the FDA
The Oct. 6 New England Journal of Medicine includes a perspective on how to “revive” the U.S. Food and Drug Administration. Read…
Amgen, FDA announce voluntary recall of Epogen and Procrit
On Sept. 24, Amgen and the U.S. Food and Drug Administration announced that Amgen is voluntarily recalling certain lots of Epogen and…
Hospira infusers recalled
On Sept. 10, the U.S. Food and Drug Administration announced the recall of the Hospira Symbiq One-Channel and Two-Channel Infusers because of…
Free online course on FDA drug regulation
Access “The Past, Present, and Future of FDA Human Drug Regulation,” a free educational program from the U.S. Food and Drug Administration…
Engage Introducer recalled
On Aug. 13, the U.S. Food and Drug Administration (FDA) announced the recall of 6 French Engage Introducers manufactured between April 27…
FDA posting postmarketing drug safety evaluations
You can access U.S. Food and Drug Administration (FDA) postings on postmarketing drug safety evaluations online. For more information, click here.
The Avandia saga
Read an interesting editorial about Avandia here. A U.S. Food and Drug Administration panel recommended keeping the drug on the market, but…
Avastin may lose metastatic breast cancer indication
An U.S. Food and Drug Administration (FDA)-advisory panel has voted to strip Avastin’s indication for metastatic breast cancer because the drug is…
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