Tag: draft guidance

FDA Holds Teleconference re: Social Media Guidance

The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors and packers that use social media and the internet to promote FDA-approved products.  The FDA has made the PowerPoint and webinar Q&As publicly available […]

FDA Releases Two Social Media Guidance Documents

The U.S. Food and Drug Administration (FDA) released today two highly anticipated draft guidance documents: Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; and Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.

FDA Enforcement of Pharmaceutical Websites Continues

The Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) recently posted an untitled letter to Institut Biochimique SA (IBSA) and Akrimax Pharmaceuticals, LLC (Akrimax), the U.S. agent for Tirosint. The OPDP raised concerns regarding IBSA’s Facebook page for Tirosint because it failed to provide any risk information regarding its use, even though Tirosint is […]

FDA Revises Draft Reprint Guidance: Includes New Recommendations for Clinical Practice Guidelines

In today’s Federal Register, the U.S. Food and Drug Administration (“FDA”) announced the availability of a revised draft guidance document titled: “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices” (the “Revised Draft Reprint Guidance”).  This revises the FDA’s 2009 draft guidance document on the subject, which was […]

FDA Releases New Draft Guidance for Postmarketing Submissions of Interactive Promotional Media

Draft guidance from the U.S. Food and Drug Administration (FDA) titled, “Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics; Availability” was published today in the Federal Register.  The FDA defines “interactive promotional media” in the […]

Available Now: FDA’s Final Guidance on Wireless Medical Devices

While the FDA has yet to issue final guidance on mobile medical applications, the FDA recently issued final guidance on radio frequency (“RF”) wireless technology in medical devices (“wireless medical devices”). For comparison, the anticipated guidance on mobile medical applications is expected to address questions such as, “Will/How will mobile medical […]

Mobile Health Apps Implicate Data Privacy and Security Laws

Privacy concerns regarding mobile devices in health care are raising eyebrows and making headlines. The Telegraph reports that “health and fitness apps have been harvesting sensitive personal data and passing it on to insurance and pharmaceutical companies” although “apps companies . . . have denied that the information is personally […]