Industry News


Patient Engagement

The EMA and the FDA have committed to engaging patients in their regulatory processes to promote patient-focused medicinal product development, as well as improve transparency and trust in the regulatory system. Highlighted are exchanges of experience between the agencies and some impacts on patient engagement.

Mobile Health

Usability in Mobile Apps

Mobile apps have become a go-to platform for both patients and healthcare providers to manage medical care. Applying human factors and usability principles to the development of such apps is critical. Xcertia, and mHealth collaborative have been working to develop industry guidelines.


IFU New Guidance from FDA

The FDA has released a new draft guidance on the content and format across IFU's used for human prescription drug and biological products and drug-device or biologic-device combination products submitted under a new drug application (NDA) or a biologics license application (BLA).


Transparency in Reporting

The FDA system of reporting has become more transparent recently. With that transparency the FDA has released over 20 years of records on medical device adverse events. FDA is working to update its Medical Device Reporting program, one of the tools they use to continue to ensure safety in the landscape of health care.


These links are provided for your convenience and are not considered to be an endorsement by Agilis Consulting