FDA 3500 Notification Form, commonly used by health professionals. See the instructions for the FDA Form 3500. Your FDA portal for clinically important safety information and for reporting serious problems with medical products for human use. Our ultimate goal is to create safe and effective products for all.
If you experience an adverse effect from one of our medications, tell your healthcare provider and then let us know. This helps us to accurately track the safety of our medications. Patients should always seek medical advice from their healthcare provider about adverse events. If you participate in a clinical trial, report the adverse event to the study coordinating center.
Report any adverse event related to any of our products by calling us at 1-800-438-1985 (in the United States only). If you prefer, you can contact the U.S. UU. Food & Drug Administration (FDA) directly.
Your country (not the US). USA, USA. UU.). To report an adverse event, ask your healthcare provider for more information or contact your local health authority.
This information, including product information, is intended for residents of the United States only. The products mentioned in this document may have different labels in different countries. If sites need to report or talk about an EA, they can call the contact number provided for registration and then they will be asked to press a number if they report an EA. The collection of AE data by a registry is generally requested intentionally (meaning that the data is part of the registry's uniform collection of information) or unsolicited (meaning that AE information is offered voluntarily or is annotated in an unsolicited way and not as a mandatory data element through a case report form).
This type of plan should also describe how deviations or systemic failures in the detection and reporting processes will be identified, addressed, and considered in order to take corrective action. In addition to addressing regulatory responsibilities for reporting adverse events, records must also understand regulatory and ethical requirements and expectations in relation to breaches of confidentiality or the reporting of other risks to patients that may arise during the course of a registry. Sponsors who are interested parties in a registry should have a representative from their internal pharmacovigilance or drug safety group, who participates in the design and review of the registry protocol and participate in the data collection and reporting process (discussed in the chapter) to facilitate adequate and timely reporting and communication. The ICH guidelines describe the standards for accelerated reporting (5, 22) and provide recommendations for periodic security update reports (23) that are generally accepted globally.
The requirements for regulated industries that sponsor or financially support a registry include the accelerated notification of serious and unexpected adverse events that are brought to their attention through spontaneous reports. In any case, sponsors should discuss the safety information requirements for their specific records with the relevant health authorities (such as the FDA and the European Medicines Agency) before finalizing their registration protocol. Other sources provide more information on the definition and reporting of EAs related to devices and product problems, and on post-marketing studies (including those related to registrations). Ultimately, registry planning and registration protocol should anticipate and clearly outline the roles, responsibilities, processes, forms, and lines of communication for AE reports for sites, registry staff, the DSMB, the DMC or award committee, if any, and the sponsoring organization.
If the event is determined to be an AE, the sponsor will include it in the safety database, evaluate it internally, and transfer the EA report to regulatory authorities if necessary. Before marketing approval, the relationship is an additional determining factor for reporting on events that occur during clinical trials or preclinical studies related to new drugs and biological products under investigation. Sponsor options include (recommending that sites report comparator EAs directly to the manufacturer or to the FDA); (collecting all AA) and sending the EA report directly to the comparator manufacturer (who, in turn, would report to the FDA); and (in fact, reporting the EA of the comparison product directly to the FDA). In fact, the FDA does not necessarily notify companies if an EA report reaches the FDA directly, since only certain reports are shared with the industry and journalists have the option of requesting that information not be shared directly with the company.
In this situation, the registry is an agent of the sponsor, and the FDA's 15-calendar day reporting requirement begins as soon as the registry becomes aware of the event. .