FDA adverse event collection workshop

FDA's Center for Drug Evaluation and Research will hold a public workshop Jan. 29 to solicit information on research approaches to assessing the public health benefit of collecting and reporting all adverse events throughout the product's marketed life cycle. The workshop objectives, co-sponsored by the Center for Biologics, are to initiate dialogue and information-sharing among stakeholders affected by postmarketing AE collection, reporting and evaluation; share current FDA practices and what questions should be addressed by requests for proposals; and obtain input on the questions and methods that will be used to conduct research. The input will be used to publish a formal request for information, followed by an RFP...