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  • Regulatory NewsRegulatory News

    Apple, Verily and J&J Among 9 Selected for FDA Digital Health Pilot

    US Food and Drug Administration Commissioner Scott Gottlieb took the stage Tuesday at AdvaMed’s MedTech conference in San Jose, California, unveiling the nine companies selected among 103 applicants to participate in the agency’s precertification pilot for digital health applications. FDA  launched the pre-cert pilot  in July as part of the agency’s  Digital Health Innovation Action Plan. The pilot participants, representing a range of companies and technology in the ...
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    Drug Marketing on Twitter: FDA to Study Space-Limited Communications

    The US Food and Drug Administration (FDA) is planning to study whether links can be sufficient means of presenting risk information about drugs in advertising on social media platforms, such as Twitter, where character space is limited. "The objective of this research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about the drug are made within character-space-limited communicati...
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    FDA Inaction Pushes McCaskill to Target Picamilon Retailers Directly

    Sen. Claire McCaskill (D-MO) is calling on ten major retailers to pull all supplements containing the ingredient picamilon after what she says has been “weeks of inaction” by the US Food and Drug Administration (FDA). The letters sent Monday to Amazon, the Vitamin Shoppe, CVS, Wal-Mart, Google, Vitamin World, Walgreens, Target, eBay and General Nutrition Corporation (GNC) call on them to pull from their shelves any dietary supplements containing picamilon as FDA has decl...
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    FDA and Google Talk 'Adverse Event Trending'

    Last month, representatives from the US Food and Drug Administration (FDA) and search giant Google met to discuss "adverse event trending," Bloomberg reports. Background Currently, FDA keeps track of adverse events submitted through voluntary and mandatory reports to its FDA Adverse Event Reporting System (FAERS). Drugmakers are required to report adverse events to the agency; however, patients and their doctors do so voluntarily, leading to serious underreporting. ...
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    Is Google a Key Part of the Future of Drug Safety? FDA Researchers Say 'Yes'

    Could the US Food and Drug Administration (FDA) soon use Google to track drug-related adverse events? In a new research letter published this week in Clinical Pharmacology & Therapeutics, two FDA researchers argue that "Internet search logs" could be substantially useful to the agency's drug regulatory staff in determining which drugs might have unforeseen adverse events. Background At present, FDA tracks those adverse events through a hybrid voluntary/mandatory rep...
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    FDA Chides Gilead for Google Advertisement, but is the Company Entirely to Blame?

    Less than a month after the US Food and Drug Administration (FDA) first unveiled its long-awaited social media guidance documents , the agency has chided Gilead Sciences for its misuse of a "text-limited" Internet platform covered by its guidance documents, Google Sitelinks. Background In July 2014, FDA released two guidance documents covering the use of social media. One of those documents, Internet/Social Media Platforms with Character Space Limitations— Pres...
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    FDA Guidance: How Can Pharma and Device Companies Use Twitter? Not Easily.

    The US Food and Drug Administration (FDA) today released two guidance documents focused on the use of social media by members of regulated industry, including one on how companies can use the social media platform Twitter and other space-limited platforms. Background The issuance of guidance on social media was required by the  Food and Drug Administration Safety and Innovation Act ( FDASIA ) , Section 1121 of which calls for FDA to, by August 2014, "issue gui...