What You Need to Know About the FDA’s MedWatch Adverse Event Reporting Program

If you are a small business working with the FDA to get a drug or medical device on the market, you are aware of the scrutiny of clinical trial design and data to ensure the safety of your product.  But the FDA is responsible for monitoring a product’s safety after it has reached the market as well.  The method that has proved most valuable in this surveillance is the implementation of MedWatch, a digital network for reporting important safety information about FDA regulated drugs, medical devices and dietary supplements. 

 On this platform, unexpected side effects, adverse events, or other problems with products can be reported by a health professional or a consumer, quickly and at the point of care.  Anyone who has access to the internet can report events but also have access to the unbiased, reported events instantly.  This spontaneous reporting system has help identify hazards with drugs that were not observed or recognized at the time of approval.  In fact, a single entry can activate actionable information that impacts treatment and diagnostic choices for professionals and their patients.

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Here we list the three components to report adverse events and medical product problems to the FDA via MedWatch. 

  1. It’s easy to report events

Just go on-line to www.fda.gov/medwatch and click on ‘report a problem’. Choose the appropriate form, depending if you are a health professional or consumer.

  1. Details matter

Include product name, lot number, and expiration date of the product.  This can be found on the product itself and usually the box it came in.

  1. Describe problem thoroughly

The form will ask when the problem started, when treatment was sought, and if/when and how the problem was solved. The more detailed information that is included on the form, the easier it is to implement actionable information for other health professionals and consumers.

If you have a product you are monitoring, you can sign up for e-mail notifications here to keep up-to-date on MedWatch safety alerts.  And if you haven’t already, be sure to sign up for our blog to keep up-to-date on tips with working with the FDA. 

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