Kevin Nelson

Kevin Nelson

Duane Morris LLP

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Latest Publications


Inch-by-Inch: FDA's New Biosimilars Guidance Inches the Industry Closer to Clinical Testing Clarity

For those under cloudy skies for two years, even a small break in the clouds would seem like a bright sunshiny day. The U.S. Food and Drug Administration's (FDA) newest draft guidance on demonstrating biosimilarity largely...more

5/16/2014 - Biosimilars Clinical Trials FDA Pharmaceutical Prescription Drugs

FDA Releases Draft Guidance on Bioequivalence Requirements for ANDA Applicants

On December 4, 2013, the U.S. Food and Drug Administration (FDA) issued a draft guidance on demonstrating bioequivalence for drugs submitted under an Abbreviated New Drug Application (ANDA). Entitled Bioequivalence Studies...more


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