Earlier this week the Department of Health and Human Services (“HHS”) published its long awaited notice of proposed rulemaking regarding the registration of clinical trials. The most significant change that would result from implementation of the proposed rule, and the one getting the most press, is the new requirement that results data be
Prescription Drugs and Medical Devices
Be Prepared Before FDA Inspectors Come Knocking: New Guidance
By Shilpa Prem on
Posted in FDA
Late last month, the FDA finalized a new guidance document, explaining the agency’s current thinking on the circumstances that may arise in connection with an establishment inspection that it would consider to impose an inappropriate limitation on its inspection authority. The Food and Drug Administration Safety and Innovation Act (FDASIA) deems a drug or…
Industry Interest by the Numbers: Comment Volume Suggests FDA Needs More Feedback from Companies on Social Media Guidance
By Benjamin M. Zegarelli on
Posted in FDA, Medical Device
As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27). FDA does not often reopen the door…