Include the phrase continued at the end of each field that has additional information continued onto another page.Indicate the appropriate Section and block number next to the narrative continuation.
Identify all attached pages as Page _ of _.If attaching additional pages, please do the following:.For narrative entries, if the fields do not provide adequate space, attach additional pages as needed.If exact dates are unknown, please provide the best estimate (see B3).Dates should be entered as DD-MMM-YYYY (for example, Octo= ).Please complete all sections that apply to your report.Please make sure that all entries are typed, printed in a font no smaller than 8 point, or handwritten using black ink.You should not send the instruction pages. Please send only and any continuation pages you add.Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
CURRENT D1 FORM PROFESSIONAL
If, for whatever reason, you do not wish to have your health professional fill out the form, you are welcome to do so yourself.īack to top Instructions for Voluntary Reporting by Health Professionals, Consumers, and Patients You may continue to use this Form FDA 3500, but can find a link to the new consumer form on the MedWatch homepage: If possible, please take the Form FDA 3500 to your health professional (e.g., health care provider, nurse or pharmacist) so you can obtain information from your medical record that can help in the evaluation of your report. Information for Consumers, Patients and Caregivers:įDA has a voluntary reporting form, Form FDA 3500B, that is customized to make the completion of the form by non-health professionals or consumers easier. They should generally not be submitted to FDA MedWatch as voluntary reports. Īdverse events involving investigational (study) drugs, such as those relating to Investigational New Drug (IND) applications, including those for cellular products administered under IND, should be reported as required in the study protocol and sent to the address and contact person listed in the study protocol. Report problems or adverse health events and tobacco product problems that include problems with e-cigarettes (also known as “vapes”), e-liquids, heated tobacco products, cigarettes, roll-your-own cigarettes, cigars, little cigars, pipes, waterpipes (also known as hookah), chewing tobacco, snuff, or snus to the Safety Reporting Portal. For additional information or assistance with filing a VAERS report, call: 1-80. Food such as beverages and ingredients added to foods.Īdverse events involving vaccines should be reported to the Vaccine Adverse Event Reporting System (VAERS).Cosmetics such as moisturizers, makeup, shampoos, conditioners, hair dyes and tattoos.Special nutritional products such as dietary supplements, medical foods and infant formulas.Combination products such as pre-filled drug syringe, auto-injectors, metered-dose inhalers, contact lens coated with a drug and nasal-spray.Medical devices such as diabetes glucose-test kit, hearing aids, breast pumps, and many more products.Biologics such as blood components, blood/plasma derivatives, blood transfusions, gene therapies, and human cells and tissue transplants.