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26 Feb 2007, 9:01 am
Food and Drug Administration has been aware of the risks since 1995. [read post]
4 Oct 2010, 10:48 pm
By James DeGiulio -- As the Food and Drug Administration begins gathering information on how to implement the new biosimilar approval pathway of the Biologics Price Competition and Innovation Act (see "FDA Planning to Hold Public Hearings on Biosimilar Approval Pathway"), the European Medicines Agency (EMA) announced that it has finalized its requirements for biosimilar antibodies, and that these requirements will be made public in November. [read post]
14 Sep 2011, 7:44 am
Food and Drug Administration that SimplyThick may cause the life-threatening necrotizing entercolotis (NEC). [read post]
23 Aug 2011, 8:45 pm
The past few years have been marked by a shocking number of high-profile recalls of medical devices that were previously approved by the Food and Drug Administration’s abbreviated investigation process, dubbed 510(k). [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]
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]
21 Dec 2022, 9:53 am
But a speedy and sometimes lax approval process by the Food and Drug Administration means some risky devices are cleared without clinical testing and receive limited oversight once on the market. [read post]
18 Oct 2010, 5:07 am
The Consumer Right to Know Food Labeling Act, available here, would require the Food and Drug Administration (FDA) to mandate labeling of genetically modified fish and would also require USDA to mandate labeling of products of cloned animals if intended for human consumption, according to the news release. [read post]
18 Mar 2009, 10:11 am
The results of Study 15 were provided only to the Food and Drug Administration — and the agency has strenuously maintained that it does not have the authority to place such studies in the public domain. [read post]
18 Jun 2015, 10:01 pm
The House Appropriations Committee has allocated a $41.5-million increase for the Food and Drug Administration’s food safety activities for fiscal year 2016, but it’s less than half of what President Obama’s budget requested. [read post]
14 Feb 2011, 6:28 am
The Globe analyzed the Food and Drug Administration's database of adverse events involving medical devices from January 2005 to June 2010. [read post]
10 Feb 2020, 9:05 pm
Food and Drug Administration (FDA) recently approved a vaccine that could contain the current outbreak and be used as a model for approving drugs during a future public health emergency. [read post]
14 Aug 2008, 10:42 pm
I was encouraged to see this mornings Statement of CSPI Food Safety Director Caroline Smith DeWaal regarding: The bipartisan FDA Food Safety Modernization Act would help refocus the Food and Drug Administration (FDA) on preventing, rather than just reacting to, food-borne disease outbreaks. [read post]
7 Oct 2018, 9:01 pm
Both companies are on notice from the Food and Drug Administration for violations of the federal Food, Drug & Cosmetic Act. [read post]
15 Aug 2016, 10:00 pm
The Food and Drug Administration’s final rule on GRAS substances in human and animal food is scheduled to take effect 60 days after it is published in the Federal Register. [read post]
8 Jul 2013, 7:38 am
Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy. [read post]
31 May 2013, 9:34 am
Though he faces powerful opponents in the makers of the drugs, the Food and Drug Administration (FDA) and the European Medicines Agency have begun investigations based on his latest study that could lead to new warnings on the drugs, or possibly their removal from the market altogether. [read post]
19 Jan 2009, 7:00 pm
Food and Drug Administration is keeping a list of products recalled due to the Salmonella threat. [read post]
19 Jan 2009, 7:00 pm
Food and Drug Administration is keeping a list of products recalled due to the Salmonella threat. [read post]
10 Feb 2022, 7:37 am
In that case, the Food and Drug Administration had issued regulations that limited children’s access to tobacco products. [read post]
