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ALS Worldwide welcomes any questions or comments you might have.  We provide free, personalized and confidential support services to anyone in the ALS community—whether you are a patient or a loved one, friend, health care professional or caregiver of someone diagnosed.

Get help now! Fill out the Online Profile Form or if you would prefer to talk with someone by email or phone first, please contact us at [email protected] or 1-608-663-0920.

For all other inquiries, please use the email form to the right and we will respond promptly to your request.Thank you.

ALS Worldwide
5808 Dawley Drive
Fitchburg, WI 53711‑7209

ALS Worldwide
September 25, 2015

The FDA Drug Approval Process

Recent research shows that 94% of people recognize the importance of clinical research in the advancement of medical science, yet 75% say that they have little to no knowledge about how the clinical research process works.

Perhaps that explains why ALS/MND patients and their loved ones often ask us questions about the U.S. Food and Drug Administration’s (FDA) drug review and approval process. For many, the various phases of clinical trials can often seem incomprehensible and perplexing. It’s our hope that this simple infographic will help explain each phase in terms anyone can understand and demystify the whole process in general.

This infographic is not meant to be a comprehensive guide, but simply a helpful starting point for people who want to understand how clinical trials fit into the overall drug development process. Please click here to view the PDF.

For a more detailed description of the various steps the FDA utilizes to ensure drugs are both safe and effective for the public, please visit the FDA's website.