United States:
FDA Announces Availability Of Safety Reporting Portal And Delays Compliance Date For Electronic Submission Of Post-Market Safety Reports
To print this article, all you need is to be registered or login on Mondaq.com.
In the May 27, 2015, Federal
Register, FDA announced the availability of the
Safety Reporting Portal for the electronic submission of
post-market, individual case safety reports, as required by
the final rule issued one year ago. FDA is also
moving the date for compliance to September 8, 2015, and will
continue to accept individual case safety reports in paper form for
90 days.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
POPULAR ARTICLES ON: Food, Drugs, Healthcare, Life Sciences from United States
Manatt Health: Health AI Policy Tracker
Manatt, Phelps & Phillips LLP
The purpose of this quarterly tracker is to identify key federal and state health AI policy activity. Below reflects federal legislative and regulatory activity to date related to AI...