Federal Register Notice: FDA is making available a draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format — Annual Reports for NDAs and ANDAs. This draft guidance is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. The document discusses issues related to the electronic submission of annual reports for approved new drug applications and abbreviated new drug applications to CDER. To download this guidance, click here. To view this notice, click here.
