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19 Apr 2015, 10:04 pm
Food and Drug Administration (FDA) exercised its recall authority granted by the Food Safety and Modernization Act (FSMA) for the second time. [read post]
11 Mar 2011, 4:08 pm
The FDA reports that about 32.3 million prescriptions for the drug and its generic forms were dispensed between January 2007 and December 2010, and roughly 4.3 million patients filled prescriptions for the drug from pharmacies in the United States. [read post]
22 Feb 2010, 8:41 am
Eon Labs Inc. has agreed to pay the United States $3.5 million to resolve False Claims Act allegations relating to the company’s drug Nitroglycerin Sustained Release (SR) capsules, the United States Department of Justice (DOJ) announced Feb. 22, 2010. [read post]
21 Jan 2010, 2:34 am
Nellie Napier was the ninth and last person on record to die from Salmonella during the outbreak that sickened more than 700 people in the United States last year. [read post]
3 Mar 2015, 10:03 pm
Food and Drug Administration (FDA) and USDA’s Food Safety and Inspection Service (FSIS). [read post]
13 Jul 2016, 10:00 pm
Food and Drug Administration is amending its final rule on the registration of food facilities to require additional information from registrants. [read post]
30 Apr 2018, 8:57 am
Food and Drug Administration (FDA) to issue a “black box” warning (the most severe the agency gives) to warn against using these medications to treat elderly patients who suffer from dementia, noting that the practice is “associated with a significantly increased risk of death. [read post]
11 Aug 2024, 9:03 pm
Hunan Gagazui Food Co., Ltd. produces low acid canned food products intended for export to the United States. [read post]
17 Nov 2009, 2:00 am
Food & Drug Administration (FDA). [read post]
4 Jan 2018, 9:53 pm
Food and Drug Administration are investigating a multistate outbreak of Shiga toxin-producing E. coli O157:H7 infections in 13 states. [read post]
29 Mar 2011, 2:59 am
Seven synthetic dyes are currently approved by the FDA for use in the United States. [read post]
3 Dec 2020, 2:08 pm
District Court for the District of Maryland is considering new evidence in our lawsuit challenging a Food and Drug Administration (FDA) policy requiring patients who need a medication used for early abortion care to travel in person to a clinical setting for the sole purpose of picking up a pill and signing a form. [read post]
10 Sep 2012, 9:16 am
The FDA Food Safety and Modernization Act (FSMA), signed into law on January 4, 2011, requires a significant regulatory shift by the Food and Drug Administration (FDA). [read post]
10 Sep 2012, 9:16 am
The FDA Food Safety and Modernization Act (FSMA), signed into law on January 4, 2011, requires a significant regulatory shift by the Food and Drug Administration (FDA). [read post]
9 Feb 2009, 5:00 am
The Second Circuit remanded the case to the United States District Court for the Southern District of New York for further proceedings.The case involves 88 Nigerian families who allege that Pfizer tested a new antibiotic, Trovafloxacin Mesylate (“Trovan”), on children in a Nigerian hospital during an outbreak of bacterial meningitis in 1996 in an attempt to gain the approval of the United States Food and Drug… [read post]
30 Sep 2015, 3:05 am
Food and Drug Administration (FDA) are investigating a multistate outbreak of Salmonella Poona infections. 671 people infected with the outbreak strains of Salmonella Poona have been reported from 34 states, an increase of 113 cases since the last update on September 22. 131 ill people have been hospitalized, and three deaths have been reported from Arizona (1), California (1), and Texas (1). [read post]
2 Jan 2019, 7:07 am
Pre-emption issues permeate prescription-drug safety litigation because the Food and Drug Administration regulates the safety and efficacy of prescription drugs under federal law, while state tort law provides the remedy for patients injured by the use of FDA-approved drugs. [read post]
30 Aug 2012, 8:43 am
One of the country's largest dialysis operators, German-based Fresenius Medical Care, was recently investigated by the nation's Food and Drug Administration (FDA) in response to a number of patient deaths. [read post]
9 Feb 2011, 1:59 am
Food and Drug Administration (FDA) has released the form 483 inspection report for Urbana, IL-based Tiny Greens Organic Farms. [read post]
11 Mar 2015, 4:47 pm
In our convoluted food safety system, FSIS generally oversees beef, chicken, pork and lamb production and the Food and Drug Administration (FDA) regulates all other manufactured food products. [read post]