Tag Archives: pediatric

NORD Summit 2016 Highlights

By Kimberley Cummings, Ph.D., RAC (US), Vice President, Scientific & Regulatory Strategy and Operations Cato Research   The National Organization for Rare Disorders (NORD) held their annual Rare Diseases and Orphan Products Breakthrough Summit in Arlington, VA on October 17th … Continue reading

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U.S. Pediatric Product Development

In the United States, there are two regulations in place regarding pediatric trials and related incentives: the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA).  The PREA requires pediatric assessments for applications submitted for changes … Continue reading

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FDA’s New Guidances for February 2013

Several new guidance documents were released by FDA in February 2013, covering a wide range of subjects. S10 Photosafety Evaluation of Pharmaceuticals Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease Class II Special Controls Guideline: Temporary Mandibular … Continue reading

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

The Rare Pediatric Disease PRV, the Difference in the PRVs, and the Future of the Program The Rare Pediatric Disease Priority Review Voucher (If you haven’t read Part 1 yet, start there first!) A new Priority Review Voucher (PRV) has … 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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