FDAs 2011 Draft Guidance on Financial Disclosure by Clinical Investigators (Clinical Compliance )
Venue: Online Event
|Event Date/Time: Nov 11, 2011||End Date/Time: Nov 11, 2011|
This Webinar will address the most pressing changes and answers questions FDA has received from industry and the public. While the â€œdraftâ€ offers much-needed clarification on certain regulatory requirements as well as invaluable insight into FDAâ€™s current thinking of enforcement, as with the current guidance, if the draft guidance is adopted, sponsors will still need to make judgment calls.
Areas Covered in the Seminar:
- Review proposed changes to the 2011 released draft guidance.
- Clarification on definition of sponsor.
- Understand FDA's clear actions that can and will be taken regarding refuse to file a marketing application.
- Time period covered by regulations.