QUESTION 1:
According to 21 CFR 314.80, “Any adverse drug experience that is not listed in the current labelling for the drug product”. Since the patient is hospitalized and the side effect is not listed in the package insert this is considered as unexpected serious adverse event. As the product used is an approved product, as per 21 CFR 313.80, this case should be reported to FDA within 15 calendar days of the initial receipt.
Reference:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.80

QUESTION 2:
Title 21 of the Code of Federal Regulations (CFR) Section 312.42 describes a clinical hold as a clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. The clinical hold order may apply to one or more of the investigations covered by an IND. When a proposed study is placed on clinical hold, subjects may not be given the investigational drug. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and placed on the investigational drug; patients already in the study should be taken off therapy involving the investigational drug unless specifically permitted by FDA in the interest of patient safety. …show more content…
CBER reviews BLA within 30 days of the date imposed and let the sponsor know through any rapid communication that a hold is being imposed and explains the process of action. On having imposed a clinical hold CBER writes a clinical hold letter to the sponsor with clear specification of reason for the hold. The reason that would lead to a clinical hold