Form 3331a
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People also ask
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What is FDA 3331?
SUBMITTING FORM FDA 3331a – FIELD ALERT REPORT. Use Form FDA 3331a to submit Field Alert Reports (FARs) for CDER- or CBER-regulated drug products that are approved under a new drug application (NDA) or abbreviated new drug application (ANDA). -
What is the FDA Form 3500 for health professionals?
Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers. -
Which form is used for mandatory adverse event reporting to FDA?
Mandatory reports are made using Form FDA 3500A Mandatory Reporting Form. You can download the mandatory form as a . pdf document for printing. (At this time, FDA does not have a 3500A form that can be submitted electronically). -
What is an FDA field alert report?
The purpose of field alert reports (FARs) is to quickly identify quality defects in distributed drug products that may present a potential safety threat. -
What is an FDA MedWatch form?
MedWatch, the FDA's medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as: Prescription and over-the-counter medicines. -
What is the difference between MedWatch Form 3500 and 3500A?
The MedWatch form, also known as Form FDA 3500A, is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers. Form FDA 3500, a condensed version of 3500A, is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients. -
What are the different types of MedWatch forms?
There are two types of MedWatch forms: MedWatch Form 3500 and MedWatch Form 3500A. -
What is Form FDA 3500a?
Form FDA 3500 may be used by health professionals or consumers for VOLUNTARY reporting of adverse events, product use/medication errors, product quality problems, and therapeutic failures for: Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers. -
How do I file an adverse event with FDA?
Call FDA at 1-800-FDA-1088 to report by telephone. Reporting Form FDA 3500 commonly used by health professionals.
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