Prepare a 1–2-page justification for an IND amendment requesting permission from

Prepare a 1–2-page justification for an IND amendment requesting permission from the FDA to supply sodium chloride (saline) for a pivotal Phase III study from an alternative manufacturer located outside the United States.
Background Information:
Getafix Pharmaceuticals plans to conduct a placebo-controlled study to assess the prognostic efficacy of IMP for diagnosing coronary artery disease. The protocol has been registered in ClinicalTrials.gov, with a Form FDA 3674 and clinical study protocol submitted to an effective IND. In addition to IMP, the protocol calls for intravenous administration of sodium chloride to all study participants. From many standpoints, Getafix is well-positioned to begin dosing patients, however, due to the impact of a recent hurricane on ABC Healthcare manufacturing facilities in Florida, current supplies of saline will soon expire. Following discussions with ABC Healthcare representatives, Getafix
is unsure of when saline supplies from Florida will be available. Since ABC facilities in Europe were not impacted by this natural disaster, Getafix would like to request use of Europe-manufactured saline for the Phase III study.
Communications between Getafix and the FDA Drug Shortage Division (which assists with commercial supply) and relevant IND review division have confirmed submission of an IND amendment requesting import of saline from outside the US is appropriate, and that the request should include detailson saline source, specification, and package insert.
Prompt:
Submit an IND amendment requesting permission to import saline to participating US sites. The request may be submitted via Section 1.11.4 Multiple Module Information Amendment
Visit https://www.accessdata.fda.gov/scripts/cder/drls/default.cfmLinks to an external site.
to locate details of an ex-US manufacturing facility that would be supportive of this request, for example, facility name, address, FDA Establishment Number, and DUNS. Describe the rationale for the request and importance of the clinical
study. Based on enrollment projections, provide a total estimated volume of saline for import.
Prepare the saline supply request in accordance with CTD format, supplemented with a cover letter and completed Form FDA 1571. Within the cover letter, briefly describe additional supporting documentation included within the IND amendment. Additional supporting documentation may include sodium chloride USPI and SmPC, a screen shot from the Drug Establishments Current Registration Site that lists the European manufacturing facility, and Certificate of GMP Compliance obtained at
http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.doLinks to an external site.nt 3