Answer: D
Prescriber safety reporting is only voluntary in FDA-approved prescription products.
Emergency Use Authorizations (EUAs): according to the conditions of authorization (mandatory for peramivir)
Investigational New Drug Applications (INDs): required per IND regulations
Emergency Investigational New Drug Applications (EINDS): required per IND regulations
FDA-Approved Prescription Products: voluntary MedWatch reporting
Reference
Debra Birnkrant, M.D., and Edward Cox, M.D., M.P.H. The Emergency Use Authorization of Peramivir for Treatment of 2009 H1N1 Influenza. Published at www.nejm.org November 2, 2009 (see Table 1 for comparison of the above 4 criteria) – Freee fulltext