Pharmacovigilance Services in USA

The USA follows a multi-faceted approach to the pharmacovigilance system. It is divided into two post-marketing systems namely, the FDA Adverse Event Report System (FAERS) for pharmaceuticals and biologic products and the Manufacturer and User Facility Device Experience (MAUDE) database for medical devices. It is voluntary for healthcare professionals, consumers, and patients to submit adverse drug reaction reports; however, it is mandatory for reporting by IND reporters, manufacturers, distributors, importers, and user facilities personnel. All adverse drug reaction reports can be submitted through the MedWatch website separately via voluntary and mandatory ADR reporting forms.

As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in USA that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.