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13 Jan 2017, 2:12 pm
Food and Drug Administration to approve ... [read post]
13 Jan 2017, 1:52 pm
Amgen (1) Whether notice of commercial marketing given before Food and Drug Administration approval can be effective; and (2) whether, in any event, it is improper to treat Section 262(l)(8)(A) – the Biologics Price Competition and Innovation Act of 2009’s “Notice of commercial marketing” provision which states that a biosimilar applicant shall provide notice to the incumbent seller of the biological product “not later than 180 days before the… [read post]
13 Jan 2017, 12:10 pm
Sandoz, the justices will consider the process for resolving patent disputes relating to the federal Food and Drug Administration’s licensing of “biologics” – products such as vaccines, viruses and antitoxins. [read post]
13 Jan 2017, 11:20 am
Food and Drug Administration (FDA), and the U.S. [read post]
13 Jan 2017, 8:22 am
Under new federal Food and Drug Administration regulations, antibiotics that are used to treat people and their diseases cannot be fed to animals principally to promote their growth. [read post]
12 Jan 2017, 10:00 pm
The Myerstown, PA, company sold the candy mix to consumers nationwide via the Internet and distributed the recalled product to 22 states, according to a recall notice on the Food and Drug Administration’s website. [read post]
12 Jan 2017, 11:23 am
At this point, the SkinGun has not yet been approved by the Food and Drug Administration, though continued research and testing is taking place. [read post]
12 Jan 2017, 11:23 am
At this point, the SkinGun has not yet been approved by the Food and Drug Administration, though continued research and testing is taking place. [read post]
12 Jan 2017, 8:24 am
On January 9, 2017, the US Food and Drug Administration (“FDA”) approved opioid drug Arymo ER (morphine sulfate) manufactured by Egalet US, Inc. [read post]
12 Jan 2017, 7:01 am
That’s all we have for the penultimate Relist Watch of the Obama Administration. [read post]
11 Jan 2017, 10:00 pm
Inc. of Orlando, FL, posted the recall with the Food and Drug Administration on Wednesday, joining almost 20 other companies that have recalled foods because of the problem with powdered milk ingredients from Valley Milk Products LLC in Strasburg, VA. [read post]
11 Jan 2017, 8:43 pm
Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). [read post]
11 Jan 2017, 8:04 am
Biosimilars are regulated as new drugs and are subject to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, as well as the data-protection provisions in section C.08.004.1 of the Food and Drug Regulations. [read post]
11 Jan 2017, 7:19 am
Amgen Inc. 15-1039 Issues: (1) Whether notice of commercial marketing given before Food and Drug Administration approval can be effective; and (2) whether, in any event, it is improper to treat Section 262(l)(8)(A) – the Biologics Price Competition and Innovation Act of 2009’s “Notice of commercial marketing” provision which states that a biosimilar applicant shall provide notice to the incumbent seller of the biological product “not… [read post]
11 Jan 2017, 7:09 am
” USA Today reports that a report by the HHS Office of the Inspector General found that the Food and Drug Administration “doesn’t require food manufacturers to quickly recall dangerous food that can cause illness or death. [read post]
10 Jan 2017, 10:00 pm
Hostess Brands LLC of Kansas City, MO, initiated a nationwide recall of its “Holiday White Peppermint Twinkies” late Monday because of a recall by Blommer Chocolate Co. of the confectionary coating used on the Twinkies, according to the recall notice on the Food and Drug Administration’s website. [read post]
10 Jan 2017, 8:15 am
And they have said that 90 percent of the medications given to newborns aren’t approved for such uses by the federal Food and Drug Administration. [read post]
9 Jan 2017, 10:01 pm
Food and Drug Administration includes selected products produced between Oct. 20, 2016, and Dec. 9, 2016, and shipped by Palmer Candy Co. to grocery, convenience store and wholesale customers nationwide,” according to the recall notice. [read post]
9 Jan 2017, 10:00 pm
Food and Drug Administration, to be filled by President-elect Donald J. [read post]
9 Jan 2017, 4:07 pm
Food and Drug Administration. [read post]
