Health Law Advisor

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 submitted for all applicable clinical trials, even those evaluating unapproved drugs and devices.   Although we agree that this new requirement is likely to have significant ramifications for drug, biologic and device manufacturers, here are ...

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 medical device adulterated if it has been manufactured processed, packed, or held in any factory, warehouse, or establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.

The ...

As reported previously in this blog and in an EBG Client Alert, FDA has recently reopened the comment periods for three draft guidance documents released this year: two on social media promotion (open until October 29) and one on informed consent information sheets (open until October 27).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 to comment after the required notice-and-comment period has closed, and the fact that FDA has chosen to do so for these draft guidances is significant.  In all three cases, FDA received communications from stakeholders requesting additional time to digest the ...