Easy Access to the Latest Drug Approvals and Patent Expirations The Food and Drug Administration (FDA) Orange Book is now in its 39th edition. The information in the book stems from the requirement of the FDA to provide states information regarding pharmaceutical therapeutic equivalence. States were creating formularies and looking for options to keep costs […]
Apple, Verily, and Samsung are among the companies joining FDA program that aims to get digital health products to market faster.
FDA Director Scott Gottlieb has announced big changes in how the FDA approaches digital health, including plans for third party certification.
The FDA is launching a digital health unit with plans to hire 13 full time employees to help step up oversight in this area.
Genos offering FDA approved home testing, with a twist.
FDA is hosting the 2016 FDA Naloxone App Competition to encourage the development of creative strategies to combat the rising epidemic of opioid overdose.
Simply asking developers to source the medical and health content they provide in apps could easily solve the quality solution in the App Store.
Apple’s new guidelines will have a bigger impact than the FDA.
The Food and Drug Administration (FDA) recently released guidance highlighting just how hands off they intend to be when it comes to health apps. When the FDA released its first guidance on which health apps it intended to regulate, it quickly became clear that they intended to focus on a pretty narrow part of the […]
New interactive Q&A tool & best practice guide help developers of health apps navigate a complex and confusing regulatory maze.
New Cybersecurity guidelines published by the FDA to prevent cyber attacks.
Determine if your medical app will require FDA regulation.