Tag Archives: biologics

AMP’d Up Search for Biomarkers

By Kathy A. Grako, Ph.D., PMP, CCRP, Senior Clinical Strategy Scientist In February the United States government announced a unique triad brought together to “accelerate the development of life saving drugs and to help identify new treatments and cures for … Continue reading

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New FDA Guidances for June 2013

FDA was busy last month and released 14 Guidances to prove it, including the long awaited Guidance discussing the Breakthrough Therapy designation that was enacted by FDASIA.  Look for a review of “Expedited Programs for Serious Conditions––Drugs and Biologics” coming … Continue reading

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New FDA Guidances for March 2013

FDA released several interesting new guidances last month, including several regarding communications with the FDA. Types of Communication During the Review of Medical Device Submissions is in accordance with the MDUFA III goals and includes descriptions of acceptance review communications, substantive … Continue reading

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Everything You Need to Know About Priority Review Vouchers: Part 1 of 2

The Basics, History, and Record of the Priority Review Voucher Program The Basics If your company’s goals include funding pipeline development or increasing speed to market you should, at least, be familiar with the concept of the Priority Review Voucher … 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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