MEDWatch form

Adverse drug readions may be reported to the FDA by completing the MedWatch form and sending it to ... 

Appendix A contains a MedWatch form, which is used by health care professionals for voluntary reporting of adverse reactions and problems with tiie drag product. Is also contains advice about voluntary reporting. This form is a part of tiie FDA medical products reporting program. 

There is at least one MedWatch form or CIOMS I form for each report. 

FIGURE 21.1. The FDA Form 3500A (as MEDWATCH form) is used to make initial reports of each and every serious drug-related event. Its use by physicians and hospitals is voluntary, however. 

Additional advantages of spontaneous reporting systems include the detection of extremely rare ADRs and ability to identify at-risk subgroups. In order to enhance the spontaneous reporting system approach, the FDA developed the MedWatch form. This form can be faxed to the agency (1-800-FDA-1078) or called in (l-800-FDA-1088). ° The forms also can be... 

By mail Use the postage-paid MedWatch form, which includes the address. To get a copy of the form call MedWatch at 1-800-332-1088, and one will be sent by mail or fax. 

In the USA, most herbal manufacturers simply write a letter to the US FDA notifying when a new product is being introduced, and sometimes with an example of the labels and tablets for identification purposes. It is unclear whether the Food, Drug and Cosmetic Act applies in this situation, but if so, then it is certainly not enforced. FDA does maintain adverse event registers for all forms of drug through the usual Medwatch forms. 

Forms are available online and can be downloaded, completed, and returned via mail, fax, or eledronic mail. See the following website www.fda.gov/medwatch/index.html... 

Department ol Health and Human Services Food and Drug Administration - MedWatch 10903 New Hampshire Avenue Building 22. Mail Stop 4447 Silver Spring, MD 20993-0002 Please DO NOT RETURN this form to this address. 

In any case, injection site responses (erythemia, edema, pain, and tenderness) and systemic responses are both evaluated in subjects (Mathieu, 1997). USFDA also has specific guidance on the tracking and reporting of adverse clinical responses to vaccines. Any adverse events or product problems with vaccines should not be sent to MedWatch but to the Vaccine Adverse Event Reporting System (VAERA), operated jointly by FDA and the national Centers for Disease Control and Prevention. For a copy of the VAERS form, call 1-800-822-7967, or download the form (in PDF format) from www.fda.gov/cber/vaers/vaersl.pdf on FDA s Website. 

Vaccine Adverse Event Reporting System (VAERS) form. For drugs and therapeutic biologies, the MedWatch (3500A) form replaces the 1639 reporting form. 

FDA does not want reports on every adverse event observed that would not be practical for reporters or FDA because of the sheer volume of adverse-event reports already being sent to the agency each year (about 130,000 in 1994). While 80-85% of these reports are submitted by the manufacturer, 10-15% are received by MedWatch directly from physicians, pharmacists, other health care professionals, and consumers. MedWatch encourages reporters to be selective by limiting their reports to events for which the outcome was serious (Table 20.2). This enables FDA to focus on those events with potentially the largest public health impact. Reporters are encouraged to fill out the reporting form as completely and accurately as possible. 

Figure 35-16 U.S. Food and Drug Administration s MEDWatch adverse drug reaction volimtary reporting form (accessed April 2007).

Food and Drug Administration - MedWatch RETURN this form... 

Figure 7. FDA MEDWatch online voluntary reporting form, contemporary. ((http//www.accessdata.fda.gov/scripts/medwatch/pdf/medwatch.pdf))...

FDA MedWatch Web site http//www.fda.gov/medwatch/Download reporting forms (PDF format) MedWatch information... 

MED Watch Global assessment No scoring involved Minutes to complete. The one-page form requires a narrative description of the problem or adverse reaction. Online submission http //www.fda.gov/medwatch/... 

FDA Form 3500A, MedWatch Mandatory Reporting Medication and Device Experience... 

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