Federal Register Notice: FDA is making available a draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format —Postmarketing Periodic Adverse Drug Experience Reports. This guidance discusses issues on electronic submission of postmarketing periodic adverse drug experience reports for drug products marketed for human use with new drug applications and abbreviated new drug applications, and therapeutic and blood products marketed for human use with biologics license applications. The document does not apply to vaccines, whole blood or components of whole blood. It is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. To download the draft guidance, click here. To view this notice, click here.
