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.
News
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…
FDA approves new device for asthma
On April 27, the U.S. Food and Drug Administration approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma…
FDA clears STERIS system
On April 5, the U.S. Food and Drug Administration cleared the STERIS System 1E Liquid Chemical Sterilant Processing System. The device is used to…
FDA orders recall of Baxter infusion pumps
On May 3, the U.S. Food and Drug Administration (FDA) announced that it has ordered Baxter Healthcare Corp. to recall and destroy all of…
New boxed warning for propylthiouracil
On April 21, the U.S. Food and Drug Administration announced the addition of a boxed warning to the label for propylthiouracil. The warning includes…
Ozone-depleting inhalers to be phased out
On April 13, the U.S. Food and Drug Administration announced that seven metered-dose inhalers used for asthma and chronic obstructive pulmonary disease will gradually…
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…
FDA approves new device for asthma
On April 27, the U.S. Food and Drug Administration approved the first medical device that uses radiofrequency energy to treat severe and…
FDA clears STERIS system
On April 5, the U.S. Food and Drug Administration cleared the STERIS System 1E Liquid Chemical Sterilant Processing System. The device is…
FDA orders recall of Baxter infusion pumps
On May 3, the U.S. Food and Drug Administration (FDA) announced that it has ordered Baxter Healthcare Corp. to recall and destroy…
New boxed warning for propylthiouracil
On April 21, the U.S. Food and Drug Administration announced the addition of a boxed warning to the label for propylthiouracil. The…
Ozone-depleting inhalers to be phased out
On April 13, the U.S. Food and Drug Administration announced that seven metered-dose inhalers used for asthma and chronic obstructive pulmonary disease…