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The following issues were identified: responding to unsolicited requests; fulfilling regulatory requirements when using [[social media tools|tools]] associated with space limitations; fulfilling post-marketing submission requirements; [[online]] [[communication]]s for which manufacturers, packers, or distributors are accountable; use of [[link]]s on the [[Internet]]; and correcting [[misinformation]]. |
The following issues were identified: responding to unsolicited requests; fulfilling regulatory requirements when using [[social media tools|tools]] associated with space limitations; fulfilling post-marketing submission requirements; [[online]] [[communication]]s for which manufacturers, packers, or distributors are accountable; use of [[link]]s on the [[Internet]]; and correcting [[misinformation]]. |
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+ | Following the hearing, the [[FDA]] and solicited written comments through a public docket that was open from September 2009 to February 2010. |
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Following this meeting the [[FDA]] did not issue any guidelines, but stated that it would "look at [Internet] issues on a case-by-case basis," while reserving the right to revaluate the need for regulations in the future.<ref>''See'' The Pink Sheet (Nov. 8, 1999), at 22 (Statement of Melissa Moncavage, DDMAC Public Health Advisor, at Drug Information Association conference on Oct. 23, 1999).</ref> |
Following this meeting the [[FDA]] did not issue any guidelines, but stated that it would "look at [Internet] issues on a case-by-case basis," while reserving the right to revaluate the need for regulations in the future.<ref>''See'' The Pink Sheet (Nov. 8, 1999), at 22 (Statement of Melissa Moncavage, DDMAC Public Health Advisor, at Drug Information Association conference on Oct. 23, 1999).</ref> |
Revision as of 03:32, 24 May 2012
Overview
On November 12 and 13, 2009, the Food and Drug Administration (FDA) held a public meeting titled Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools to discuss issues related to the promotion of FDA-regulated medical products on the Internet and social media tools.
The following issues were identified: responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; online communications for which manufacturers, packers, or distributors are accountable; use of links on the Internet; and correcting misinformation.
Following the hearing, the FDA and solicited written comments through a public docket that was open from September 2009 to February 2010.
Following this meeting the FDA did not issue any guidelines, but stated that it would "look at [Internet] issues on a case-by-case basis," while reserving the right to revaluate the need for regulations in the future.[1]
References
- ↑ See The Pink Sheet (Nov. 8, 1999), at 22 (Statement of Melissa Moncavage, DDMAC Public Health Advisor, at Drug Information Association conference on Oct. 23, 1999).
See also
External links
- Transcript of Day 1 (Nov. 12, 2009).
- Transcript of Day 2 (Nov. 13, 2009).