Tag Archives: PMA

New FDA Guidances for January 2013

FDA has already released a handful of new guidances to start off the year 2013.  They include: Guidance for Industry and FDA Staff: Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA Humanitarian Use … Continue reading

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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 … Continue reading

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FDA’s Last Guidances for 2012

FDA closed out 2012 by releasing several new guidance documents, including: FDA Oversight of PET Drug Products — Questions and Answers Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs Specifications for Preparing and Submitting Summary Level Clinical Site … Continue reading

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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 … Continue reading

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New Guidances from FDA for October 2012

FDA released four notable new guidances in October 2012, with a focus on guidances related to medical devices: Guidance: E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs — Questions and Answers (R1) Guidance: FDA and … Continue reading

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