One of the most discussed aspects of healthcare has to be how to balance cost, quality and access. This is especially true when it comes to the pharmaceutical industry, particularly with the rapid growth of and increased focus on highly effective, but highly expensive, specialty drugs. Discussions about these costs are no longer isolated to negotiations between pharmaceutical companies, PBMs and insurers; instead it appears that price and cost are on FDA’s radar.
For example, the Oncologic Drugs Advisory Committee (“ODAC”) hearing, earlier this month, was not only historic because ODAC unanimously recommended FDA approve the first biosimilar product under … Continue Reading
WHEN: Thursday, February 26, 2015
TIME: 12:00pm – 1:30pm EST
To register for this webinar, please click here.
Please join us for a complimentary webinar addressing wireless health regulatory issues. This session will discuss recent trends in health technology regulation; including Food and Drug Administration (FDA) developments, Federal Communications Commission (FCC) requirements, wireless technology and communication issues, mobile applications, decision support and other Health IT challenges, and privacy and cyber security considerations.
This session is relevant to tech companies, communications companies, entrepreneurs, and developers that are entering the wireless health technologies space or considering acquiring mobile health assets.
Topics … Continue Reading
When FDA published its draft guidance Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices in June 2014, I, like many others with an interest in pharmaceutical and medical device promotion, believed that the issue of social media promotion of drugs and medical devices was largely settled. Even with the limited concessions offered by FDA to reduce the traditional risk disclosure requirements, absent a substantial shift in FDA’s position, Twitter was not going to be a medium that drug and device companies could use to effectively promote their products. Sure, companies … Continue Reading