FDA To Share Nanotoxicology Information

According to this FDA Law Blog post, Nanotech Update: FDA Enters Into MOU With Air Force Research Laboratory to Facilitate Sharing of Nanotoxicology Information, "FDA’s National Center for Toxicological Research (“NCTR”) has entered into a Memorandum of Understanding (“MOU”) that provides for the sharing of nanotoxicology information with the Air Force Research Laboratory, 711 Human Performance Wing, Human Effectiveness Directorate, Biosciences and Protection Division (“AFRL”). " 

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New Technique Might Help Diagnose Mesothelioma

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This Medical News Today article reports a new technique that might be helpful in diagnosing mesothelioma, New Technique Can Help Diagnose Mesothelioma. A new technique may help clinicians diagnose patients presenting with a pleural effusion (accumulation of fluid in the pleural cavity) of unknown cause. One of the causes of pleural effusion is malignant pleural mesothelioma, a relatively rare cancer. Currently, the first-line test for mesothelioma in patients with a pleural effusion is pleural fluid cytology, but this test isn't very sensitive. The research study results demonstrate that pleural fluid mesothelin levels were over six times greater in patients with mesothelioma than in patients with metastatic carcinomas, and ten times greater than in patients with benign effusions. This means serum mesothelin is a diagnostic biomarker for mesothelioma. Pleural fluid values are significantly higher than serum levels and may offer additional value over pleural fluid cytology for diagnosis of pleural malignancy. Additionally, pleural fluid mesothelin is a valuable adjunct to cytological examination in patients with an undiagnosed pleural effusion. Read the research study abstract: Clinical Impact and Reliability of Pleural Fluid Mesothelin in Undiagnosed Pleural Effusions 

Previous Posts: Hidden Health and Financial Liabilities of Nanotechnology CDC Says Mesothelioma Deaths Increasing 

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FDA Announces Doubling Of Foreign Inspections

According to this FDA News article, FDA to Double Foreign GMP Inspections This Year, the FDA is going to double its inspections of facilities for good manufacturing practice (GMP) compliance this year. 

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FDA Launches New Tobacco Products Center

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The Food & Drug Administration (FDA) has launched its new FDA Center for Tobacco Products. The Center will oversee the implementation of the Family Smoking Prevention & Tobacco Control Act signed by President Obama in June 2009. The FDA's responsibilities under the law include setting performance standards, reviewing premarket applications for new and modified risk tobacco products and establishing and enforcing advertising and promotion restrictions.

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FDA Proposes Electronic Safety Reporting

The FDA states in their news release, FDA Proposes Mandatory Electronic Safety Reporting - New Rules will Help Strengthen Postmarket Safety Data Collection, that they've issued two proposed rules — one that applies to electronic medical device adverse event reporting, and one that applies to electronic drug and biologic product adverse experience reporting. The proposed rules would not change what types of incidents are required to be reported to the FDA—it would require that the incidents be reported in an electronic format that the FDA can process, review, and archive. Additional Information From the FDA:

• FDA’s Web site on Electronic Medical Device Reporting: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
• FDA’s Web site on the FDA eSubmitter: http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm
• Fact Sheet: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm179586.htm

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