FDA Draft Guidance: Providing Submissions in Electronic Format--Postmarketing Safety Reports

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Submissions in Electronic Format--Postmarketing Safety Reports." This draft guidance provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments), and other postmarketing safety reports) for certain human drug and biological products. FDA is issuing the draft guidance to help persons required to submit postmarketing safety reports comply with the final rule. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by 60 days after date of publication in the Federal Register. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 3128, Silver Spring, MD 20993. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit writt...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs