FDA Adverse Event and Product Experience Reporting Systems (MEDWATCH and SPS electronic and paper-based collection)

ICR 202411-0910-004

OMB: 0910-0291

Federal Form Document

IC Document Collections

IC ID	Document Title	Status
272442	CBER, Form FDA 3500A Instruction	New
253752	Electronic Submissions of Voluntary Submissions including via SRP	Removed
253750	Submissions via SRP, including voluntary submissions	Modified
233178	Written Request for temporary waiver of mandatory electronic reporting	Unchanged
216812	CBER/CDER Form FDA 3500B Form and Instruction	Modified
216808	CTP Form FDA 3500	Modified
216806	HFP Form FDA 3500A Form	Modified
216802	HFP Form FDA 3500 Form and Instruction	Modified
216800	CDRH Forms FDA 3500, FDA 3500B Form and Instruction	Modified
216796	CBER/CDER Form FDA 3500 Form	Modified