Posts tagged with: "fda"
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16 Jul 2011, 9:49 am
The FDA has warned about the potential for excess radiation exposure in patients who underwent heart scans involving a radioactive drug called CardioGen-82.Bracco Diagnostics Inc. is the maker of this drug. [read post]
10 Feb 2009, 10:16 pm
The FDA believes that establishing a REMS for opioids will reduce these risks, while still ensuring that patients with legitimate need for these drugs will continue to have appropriate access. [read post]
2 Jul 2011, 9:55 am
The FDA oversees the regulation of medical devices and more than $1 trillion annually worth of food, drugs, dog food, cosmetics, and other products. [read post]
5 Jul 2012, 12:56 pm
The FDA is warning Zofran (ondansetron) users that a single 32 mg intravenous dose of the nausea drug could cause a life-threatening heart arrhythmia. [read post]
22 May 2012, 7:28 am
The FDA is currently reviewing Pfizer’s experimental Rheumatoid Arthritis drug Tofacitinib to determine whether its benefits outweigh risks of cancer and other infections. [read post]
11 Feb 2010, 9:08 am
The FDA wanted to see the audit report, and according to the court, the defendant "provided evasive, if not false, information to the FDA. [read post]
9 Nov 2022, 5:00 am
Drugs and the FDA thus invites readers to consider whether the FDA’s revocation of Avastin’s breast cancer indication was an appropriate curtailment of patient autonomy. [read post]
17 May 2024, 12:07 pm
Madris Kinard, a former FDA manager who founded Device Events, which analyzes FDA data, said it defies belief that Johns Dental never received a complaint worthy of relaying to the FDA. [read post]
9 Apr 2024, 9:05 pm
” The FDA conducted a similar sampling and testing program in 2021 and 2022. [read post]
12 Sep 2011, 10:15 am
The FDA has issued an official warning letter to the makers of the hair straightening products company “Brazilian Blowout” over issues of adulteration and misbranding. [read post]
21 Jul 2011, 10:22 am
The FDA has issued a warning to Zoll, a medical device maker, over concerns that the company does not properly test the battery life on their life-saving AED devices. [read post]
7 Feb 2012, 9:30 pm
The FDA would not respond to manufacturers who have failed to pay their required fees. [read post]
26 Jul 2011, 4:33 pm
FDA Drug Safety Communication: FDA alerts healthcare professionals to stop performing heart scans with CardioGen-82 due to potential for increased radiation exposure in patients [read post]
28 Apr 2009, 10:47 am
The document also explains the FDA still lacks sufficient data to answer all the questions surrounding the use of front-of-pack nutrition symbols. [read post]
14 Jan 2015, 7:39 am
In a recent piece in the Journal of the American Medical Association, three FDA officials, including Janet Woodcock, who heads the FDA Center for Drug Evaluation and Review, argue that such a singular focus on one medication will not help resolve the drug use epidemic. [read post]
8 Apr 2009, 6:24 am
I found notable the comment from an FDA spokesperson that the FDA hadn't contacted Google and other search engines because "its policy is not to contact third parties that carry drug ads, even if they violate agency rules. [read post]
11 Mar 2023, 11:09 am
So, what has been the FDA’s response? [read post]
11 Jun 2024, 9:02 pm
Use link above to go to FDA page with links to specific alerts. [read post]
19 Jun 2015, 7:05 am
Reuters reports that Insulet Corp. announced on Wednesday that it had received an FDA warning letter over some of its insulin pumps, following an FDA inspection of its Billerica, MA facility in March. [read post]
17 Nov 2009, 9:30 pm
Foley (Florida International University College of Law) has posted Teaching the Elephant to Dance: Privatizing the FDA Review Process on SSRN. [read post]
