Tag Archive: OTC

Jan 30

Combination Products: What’s New?

A monoclonal antibody combined with a therapeutic drug. An EpiPen®. A drug packaged with its delivery device. All of these are examples of combination products. A combination product, according to the FDA, is “a product composed of any combination of a drug and a device; a biological product and a device; a drug and a …

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Dec 06

FDA’s New Guidances for November 2012

Several new guidance documents were released by FDA in November 2012, covering a wide range of subjects.  The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug …

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Dec 06

FDA's New Guidances for November 2012

Several new guidance documents were released by FDA in November 2012, covering a wide range of subjects.  The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug …

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Jul 18

New Guidances from FDA – June 2011

Guidance

Here’s a list of the guidances released by FDA in June 2011, compiled by Cato Research Regulatory Scientist Cathy Anderson. Q11 Development and Manufacture of Drug Substances (Draft) Applying Human Factors and Usability Engineering to Optimize Medical Device Design (Draft) Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics (Draft) …

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