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The Society of Clinical Research Associates (SOCRA) is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities. The FDA section features all the clinical research in FDA, news, insights and more!
SOCRA Blog » FDA
1y ago
In Interview with
Andrace De Yampert, MS
This Women’s History Month, we’d like to express our gratitude to those in the clinical research community who dedicate their careers to advancing inclusivity and equality in our field. Whether through small acts of empowerment or sweeping organizational changes, every effort helps pave the way for a brighter future for all.
In the spirit of empowering women in clinical research, this post will introduce you to the Women’s Investigator Network (WIN) and the women behind it. This distinctive program at the Food & Drug Administration ..read more
SOCRA Blog » FDA
1y ago
U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA).
As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States.
Of the 46,391 participants in the clinical trials that supported the 48 novel drugs approved by the FDA in 2019, 60% of the participants were loc ..read more