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CDER & CBER Real World Data and Real World Evidence

NewsBy PDG Regulatory Expert December 20, 2021

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs…

Why is the FDA Pre-submission tool underused?

Other BlogBy Third-Party Contributor July 23, 2021

Introduction Food and Drug Administration is a government entity in the United States whose objective is to protect the public by verifying that nutritional supplements are safe to use and accurately labelled. Businesses can even use the FDA Pre-submission to get feedback on possible and planned medical advice, biologics and medication submission. It’s a fantastic…