Examples of Serious Adverse Drug Experience in a sentence
Upon receipt of any such information concerning any Serious Adverse Drug Experience or unexpected adverse drug experience or information that would require an IND safety report as described in 21 CFR 312.32 by either PRONOVA or RELIANT, the Parties shall promptly consult each other and use commercially reasonable efforts to arrive at a mutually acceptable procedure for taking such possible actions as appropriate or required under the circumstances.
Each party shall consult with, and reasonably consider input of the other party in making the determination whether any complaint, Adverse Drug Experience Report or Serious Adverse Drug Experience Report must be reported to the FDA or any other Governmental or Regulatory Authority or any other Person.