Wednesday, December 23, 2009

The FDA Responds to Questions from FDASM Community About “Next Steps” for Internet & Social Media guidelines of FDA-regulated products

The following was received 12/23/2009 @ 1 PM EST along with a 10-PAGE PDF RESPONSE.

Click here to download the PDF.

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Dear Fabio and the FDASM Community,

Thank you for submitting your questions. We found them to be useful in identifying general issues for policy development. However, please note that we are unable to provide additional comments on some of the questions in this forum as we need to adhere to FDA's Good Guidance Practices (GGP's).

FDA welcomes research, data, and comments from its stakeholders and the public on any current issues related to Internet and social media promotion and adverse event reporting of FDA-regulated medical products and encourages submissions of written and electronic comments to this docket, which closes on February 28, 2010. We are committed to getting the best information as possible in helping inform our policy. Once the docket closes and we review all the comments, we will be able to determine next steps.

Again, we appreciate your continue support of this important endeavor, which we believe will aid FDA in achieving its objective of ensuring that consumers and healthcare professionals have access to accurate, balanced, and timely information about medical products.

Kind regards,

Thomas Abrams, Director, Division of Drug Marketing, Advertising, and Communications (DDMAC)

Kristin Davis, Deputy Director, DDMAC

Mark Askine, Associate Director, DDMAC

Jean-Ah Kang, Special Assitant to the Director, DDMAC

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