FDA explains new user fee program for DTC TV ads


FDA issues notice explaining new DTC TV ad user fee program

In the Oct. 25 Federal Register, the FDA is asking companies to notify the agency within 30 calendar days if they intend to participate in the direct-to-consumer (DTC) user fee program during fiscal year 2008. If they do plan to participate, the firms are also asked to identify the number of TV ads for prescription drugs and biological products they plan to submit for advisory review during fiscal year 2008. Written responses should be submitted by Nov. 26. Responses can be e- mailed to dtcp@fda.hhs.gov. The new user fee program was established by the FDA Amendments Act of 2007.

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