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17 Apr 2018, 8:33 am
It’s a long process, one that was ultimately shortened in 1984 for generic drug makers, so long as they indicated their generic drug was equivalent to an approved brand name drug with the same active ingredients, administration, dosage and strength. [read post]
12 Dec 2016, 10:01 pm
Food and Drug Administration that followed years of congressional debate. [read post]
2 Oct 2013, 10:03 pm
Food and Drug Administration’s current rulemaking to implement the Food Safety Modernization Act (FSMA) has picked up a powerful lobbying ally. [read post]
17 Jul 2019, 7:15 am
Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention (CDC), state and local partners in the U.S., and with the support of the Canadian Food Inspection Agency (CFIA), are investigating a multistate outbreak of E. coli O121 and E. coli O103 illnesses linked to ground bison supplied by Northfork Bison Distributions Inc. of Saint-Leonard, Québec, Canada. [read post]
17 Apr 2019, 4:14 pm
Food and Drug Administration (FDA) are monitoring the outbreak. [read post]
16 Jul 2019, 5:30 pm
Food and Drug Administration (FDA), and the Canadian Food Inspection Agency are investigating a multistate outbreak of E. coli O103 and E. coli O121 infections. [read post]
10 Apr 2018, 7:59 pm
Food and Drug Administration, and the U.S. [read post]
31 Oct 2020, 9:02 pm
FSMA for the first time put the Food and Drug Administration (FDA) on the farm or at least all the farms growing produce. [read post]
24 Nov 2015, 1:26 pm
Food and Drug Administration, the U.S. [read post]
23 Jan 2015, 3:16 pm
Food and Drug Administration (FDA) to investigate a multistate outbreak of Salmonella Enteritidis infections. [read post]
17 Jul 2019, 9:18 pm
Food and Drug Administration (FDA), and the Canadian Food Inspection Agency are investigating a multistate outbreak of E. coli O103 and E. coli O121 infections. [read post]
14 Jun 2018, 9:02 pm
The Food and Drug Administration has released a list of specific store locations — in addition to retail chains — that sold pre-cut melon that has been recalled because of a multi-state Salmonella outbreak. [read post]
27 Jun 2024, 10:16 am
Food and Drug Administration (FDA) recently issued “Diversity Action Plans to Improved Enrollment of Participants from Underrepresented Populations in Clinical Studies. [read post]
26 Nov 2019, 1:20 pm
The federal Food and Drug Administration (FDA) recently issued a consumer update regarding products containing cannabis or cannabis-derived compounds, including cannabidiol (CBD). [read post]
2 Sep 2011, 7:43 am
Del Monte Fresh Produce has filed lawsuits against the Food and Drug Administration (FDA) and the Oregon Health Authority’s Public Health Division over an import ban on their Guatemalan cantaloupes last March. [read post]
31 Oct 2011, 8:29 am
Food and Drug Administration, Bacillus cereus is a microorganism that can cause diarrhea, nausea and/or vomiting. [read post]
20 Sep 2011, 10:18 am
Food and Drug Administration. [read post]
9 Dec 2008, 9:58 am
District Court for the Northern District of Illinois recently held that the Food and Drug Administration’s (“FDA”) extensive premarket approval (“PMA”) process for Class III medical devices preempts state law causes of action for injuries allegedly caused by those devices. [read post]
28 Jan 2010, 4:51 am
Drug-drug interactions are not the only type of potentially dangerous drug interactions; there can also be drug interactions with foods, beverages, and dietary supplements. [read post]
22 Dec 2008, 11:03 pm
The Abstract of this article from The Annals of Pharmacotherapy describes how the researchers looked to detect this Ketek safety signal regarding liver damage, or hepatotoxicity, by using four "commonly employed" data mining algorithms (DMAs): METHODS: Based on the Adverse Events Reporting System (AERS) database of the Food and Drug Administration, 4 DMAs, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the… [read post]