Common use of COMPLAINT REPORTING Clause in Contracts

COMPLAINT REPORTING. 1. Complaints reported directly to Miles will be summarized and forwarded to the Supervisor of Clinical Affairs at Schein. 2. All adverse drug experience complaints reported to Miles will be communicated to Schein within three working days of report receipt. Schein will be responsible for completion and submission to the Food and Drug Administration of Form FDA-3500A where appropriate . 3. Complaint reports which may meet NDA-Field Alert Report Criteria t21 CFR 314.81 (b) (1)] will be promptly communicated to Schein enabling FDA notification by Schein within three working days. Schein will advise Miles of NDA Field Alert Report submission and forward a copy of any such report to the Complaint Coordinator (see A.1 above) of Miles.

COMPLAINT REPORTING. 1. Complaints reported directly to Miles will be summarized and forwarded to the Supervisor of Clinical Affairs at Schein. 2. All adverse drug experience complaints reported to Miles will be communicated to Schein within three working days of report receipt. Schein will be responsible for completion and submission to the Food and Drug Administration of Form FDA-3500A where appropriate appropriate. 3. Complaint reports which may meet NDA-Field Alert Report Criteria t21 CFR ▇▇▇▇▇▇▇▇ [▇▇ ▇▇▇ 314.81 (b) (1)] will be promptly communicated to Schein enabling FDA notification by Schein within three working days. Schein will advise Miles of NDA Field Alert Report submission and forward a copy of any such report to the Complaint Coordinator (see A.1 above) of Miles.