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20 Jun 2012, 10:00 am
(KV) for making false or misleading statements to the US Food and Drug Administration (FDA). [read post]
11 May 2016, 3:33 am
Vaping isn’t the only issue on which the Food and Drug Administration has stopped its ears to distress cries from the regulated community. [read post]
28 Jun 2011, 9:23 am
Food and Drug Administration is not doing enough to follow up on defective medical devices, such as the recently recalled DePuy hip replacement system, that cause deadly side effects. [read post]
23 Oct 2010, 6:35 am
The Federal Food & Drug Administration has notified healthcare professionals and patients that it has identified a patch that released its active ingredient faster than the approved specification. [read post]
8 Aug 2009, 7:26 am
“The online marketing wake-up call that the Food and Drug Administration sent in early April to 14 pharmaceutical companies — in the form of letters ordering them to change how they approach search-engine advertising — has altered how, and even whether, pharma companies use Google and Yahoo to reach potential customers. [read post]
25 Sep 2010, 3:57 pm
The Federal Food & Drug Administration has announced a voluntary recall for milk- and soy-based formulas distributed in the United States, Puerto Rico, Guam, and some Caribbean nations under the Similac brand. [read post]
3 May 2017, 7:01 am
” The Tribune mentions that the Food and Drug Administration “filed a consent decree against Medtronic in 2015 for repeated failures to correct manufacturing problems. [read post]
21 Jun 2012, 2:49 pm
The implicated sprouts are in 6-ounce, clear plastic containers with a Universal Product Code of 75465-55912, according to the recall notice posted by the Food and Drug Administration on June 21. [read post]
7 Jan 2010, 4:00 pm
The Food & Drug Administration prompted Philips Healthcare (AEX:PHI) to issue a voluntary recall notice on four models of its Avalon fetal monitor after receiving complaints that the devices were providing inaccurate readings. [read post]
27 Jan 2009, 2:36 pm
The US Food and Drug Administration (FDA) has announced that these implants were shipped to a facility in Urilla, Canada and Mindeau, Canada. [read post]
29 Oct 2015, 7:47 am
The Washington Post “To Your Health” reports that the Food and Drug Administration on Monday ordered duodenoscope makers Olympus America, Fujifilm Medical Systems and Hoya Corp to “conduct real-world evaluations on how well health care workers are cleaning and disinfecting the devices. [read post]
19 Nov 2021, 11:06 am
The Food and Drug Administration (FDA) recently posted a new warning regarding a potentially fatal defect in the Medtronic Micra leadless pacemaker devices. [read post]
20 Nov 2014, 11:03 pm
Food and Drug Administration’s enforcement report. [read post]
6 May 2016, 3:29 pm
Food & Drug Administration’s past guidance regarding the need to balance cybersecurity safeguards and the usability of the medical device in its intended environment of use. [read post]
29 Sep 2011, 9:59 pm
Food and Drug Administration declared that it would release regulatory guidelines for biosimilars by the end of 2011, and since the FDA's announcement, the biotechnology industry has eagerly awaited the agency's insight on gaining approval for biosimilars in a potentially multi-billion dollar U.S. market. [read post]
17 Jun 2012, 5:57 pm
The Food and Drug Administration announced this week that oysters, clams, mussels and some types of scallops imported from Korea may be contaminated with norovirus--a virus that can cause stomach pains, nausea, and diarrhea. [read post]
5 Oct 2021, 6:34 am
Convenience Store News reports, “Thirty-one state attorneys general are pushing the Food and Drug Administration (FDA) to exercise its regulatory authority to eliminate youth-appealing flavors, limit nicotine levels, and restrict marketing of new tobacco products. [read post]
21 Nov 2010, 9:20 pm
By James DeGiulio -- Earlier this month, we reported that a major issue discussed at the Food and Drug Administration's public hearings on the implementation of the Biologics Price Competition and Innovation Act (BPCIA) concerned the standards that the FDA will require for clinical testing of biosimilars (see "Clinical Trial Requirements Are Top Issue at FDA Hearings on Biosimilars"). [read post]
16 Mar 2011, 5:15 am
Food and Drug Administration to market generic copies” while claiming the Gilead patent isn’t valid, according to the complaint filed by Maryellen Noreika, a lawyer for the plaintiffs.Maryellen Noreika is a member of the Intellectual Property Litigation Group of Morris, Nichols and is a 1993 graduate of the University of Pittsburgh School of Law.The patent in question is US 5,763,483: “Carbocyclic compounds” to inventor Bischofberger et. al. and… [read post]
THEY TOLD ME IF I VOTED FOR JOHN MCCAIN . . . OH, HELL, YOU KNOW THE REST: FDA staffers sue agency …
30 Jan 2012, 3:51 pm
. “The Food and Drug Administration secretly monitored the personal e-mail of a group of its own scientists and doctors after they warned Congress that the agency was approving medical devices that they believed posed unacceptable risks to patients, government documents show. . . . [read post]
