Glossary
Periodic Adverse Drug Experience Report (PADER)
What is PADER?
Periodic Adverse Drug Experience Report (PADER) is a safety report that pharmaceutical companies are required to submit to regulatory authorities, such as the FDA after obtaining marketing approval. The main purpose of PADER is to identify and manage potential new safety signals or adverse drug experiences associated with product, provide summary of changing post approval safety information to the regulatory authorities. It also updates and evaluates a medicine’s global data and provides information about drug safety. This evaluation offers insights, into medicine labelling and required additional investigations
What are the specifications of PADER in pharma?
PADER provides summary of drug reactions and other safety related information for a pharmaceutical product. It is required to be submitted by a sponsor or marketing authorization holder (MAH) to the US FDA after obtaining marketing authorization approval for a drug. The regulatory basis of PADER is FDA 21 CFR Chapter 1 Subchapter D Part 314.80 which gives the details on adverse drug experiences.
How does PADER ensure regulatory compliance?
PADER provides features like electronic batch records, and automatic data logging to help manufacturers comply with Good Manufacturing Practices (GMP) and other regulatory standards.
