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The First OPDP Warning Letter of the Year Goes to…

…Sodium Acetate, or 11-C Acetate, an unapproved drug. OPDP wrote their first warning letter of the year to an investigational drug at the Phoenix Molecular Imaging Center. They’ve claimed that 11-C, which acts as a PET scan for detecting recurrent prostate cancer, is misbranded.

As there is a grey area for Phoenix answering various, everyday questions of “what is available,” “how do they compare,” and “what are the parameters for successful imaging,” the FDA claims that their webpage is promoting the investigational drug as safe and effective while still going under investigation.

You can read more on this particular case on FiercePharma now!

Join us at the 6th Promotional Review Committee Compliance and Best Practice – Midwest on May 15–17 in Chicago as attendees learn to maintain accuracy in promotional materials and avoid receiving OPDP letters, especially when working with investigational drugs. This is the only conference dedicated to best practices on technical regulatory environments and operational needs for promotional review professionals.

Download the Brochure

To register, please call 866-207-6528 or click here

posted in ExL Events News

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