Search for: "U.S. Food and Drug Administration"
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23 Apr 2012, 9:59 pm
Food and Drug Administration on April 2, Abbott Laboratories requested that the FDA refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act (BPCIA) that cite reference products (biologics) for which a biologics license application (BLA) was submitted to the FDA prior to March 23, 2010. [read post]
21 Apr 2020, 6:28 am
Food and Drug Administration “modified its stance on COVID-19 and vaping, saying it has an unknown effect on the risk” of the disease, “while warning that smoking can create worse outcomes. [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]
14 Sep 2011, 7:44 am
Food and Drug Administration that SimplyThick may cause the life-threatening necrotizing entercolotis (NEC). [read post]
30 Jan 2012, 1:29 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]
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]
7 Mar 2024, 12:50 pm
Food and Drug Administration (FDA) has not approved. [read post]
28 Feb 2011, 9:55 pm
Food and Drug Administration (FDA). [read post]
28 Feb 2011, 9:34 am
Food & Drug Administration (FDA) recently acknowledged the risk of zinc poisoning associated with denture cream usage. [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]
28 Dec 2011, 7:11 am
Food and Drug Administration recently notified healthcare professionals of a Class I recall of CareFusion AVEA Ventilators. [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]
26 Feb 2007, 9:01 am
Food and Drug Administration has been aware of the risks since 1995. [read post]
20 Nov 2014, 11:03 pm
Food and Drug Administration’s enforcement report. [read post]
20 May 2012, 9:16 pm
Food and Drug Administration held a public hearing on the Draft Guidance on Biosimilar Development, where researchers, payors, patient and physician groups, and industry advocates provided their thoughts on the FDA's first attempt to clarify the logistics as to the operation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). [read post]
28 Dec 2011, 7:11 am
Food and Drug Administration recently notified healthcare professionals of a Class I recall of CareFusion AVEA Ventilators. [read post]
18 Sep 2011, 1:12 pm
The massive Food & Drug Law casebook by noted scholars Peter Barton Hutt, Richard Merrill, and Lewis Grossman has an excellent unit on the Regulation of Food Labeling. [read post]
29 Sep 2011, 7:52 am
Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills,” Food and Drug Administration. [read post]
29 Sep 2011, 7:52 am
Food and Drug Administration (FDA) is informing the public that it has not yet reached a conclusion, but remains concerned, about the potential increased risk of blood clots with the use of drospirenone-containing birth control pills,” Food and Drug Administration. [read post]
8 May 2011, 7:43 pm
Taylor, Deputy Commissioner for Foods at the U.S. [read post]
