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.
News
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…
FDA halts Avandia trial enrollment
The U.S. Food and Drug Administration (FDA) notified GlaxoSmithKline that the post-marketing trial of Avandia (rosiglitazone) is on “partial clinical hold,” meaning no new…
Infusion pump resource from FDA
The U.S. Food and Drug Administration has devoted a section of its website to infusion pump safety. It includes a link for reporting an…
FDA announces July 22-23 meeting to discuss extended-release and long-acting opioid analgesics
The U.S. Food and Drug Administration announced a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and…
FDA approves new drug for osteoporosis
On June 1, the U.S. Food and Drug Administration (FDA) approved Prolia (denosumab), an injectable treatment for postmenopausal women with osteoporosis who are at…
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…
FDA halts Avandia trial enrollment
The U.S. Food and Drug Administration (FDA) notified GlaxoSmithKline that the post-marketing trial of Avandia (rosiglitazone) is on “partial clinical hold,” meaning…
Infusion pump resource from FDA
The U.S. Food and Drug Administration has devoted a section of its website to infusion pump safety. It includes a link for…
FDA announces July 22-23 meeting to discuss extended-release and long-acting opioid analgesics
The U.S. Food and Drug Administration announced a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug…
FDA approves new drug for osteoporosis
On June 1, the U.S. Food and Drug Administration (FDA) approved Prolia (denosumab), an injectable treatment for postmenopausal women with osteoporosis who…
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