The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Providing Submissions in Electronic Format–Postmarketing Safety Reports.” This draft guidance provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs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 FDA is issuing the draft guidance to help persons required to submit postmarketing safety reports comply with the final rule.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by 60 days after date of publication in the Federal Register.
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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Submit electronic comments on the draft guidance to http://www.regulations.gov.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 written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
For further information concerning human drug products: Jean Chung, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4466, Silver Spring, MD, 20993-0002, 301-796-1874.
For information concerning human biological products: Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, rm. 7268, Silver Spring, MD, 20993-0002, 240-402-7911.
A. Background
FDA is announcing the availability of a draft guidance for industry entitled “Providing Submissions in Electronic Format–Postmarketing Safety Reports.” This draft guidance provides general information pertaining to electronic submission of postmarketing safety reports (ICSRs, ICSR attachments, and other postmarketing safety reports) for the following products:
- Drug products marketed for human use with approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs);
- Prescription drug products marketed for human use without an approved NDA or ANDA;
- Biological products, other than vaccines, marketed for human use with approved biologic license applications (or BLAs);
- Nonprescription (over-the-counter or OTC) human drug products marketed without an approved application.
This draft guidance does not apply to vaccines, human cells, tissues, and cellular and tissue-based products regulated under section 361 of the Public Health Service Act, whole blood, components of whole blood, or lot distribution reports.
This draft guidance revises and replaces the draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format–Postmarketing Individual Case Safety Reports,” issued on June 12, 2008 (73 FR 33436). Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to require that mandatory postmarketing safety reports for human drug and biological products be submitted to FDA in an electronic format that the Agency can process, review, and archive. The revised draft guidance is intended to help persons subject to mandatory postmarketing safety reporting requirements comply with the final rule.
Along with other information, the revised draft guidance provides updated information about the following: (1) Options for submitting postmarketing safety reports to FDA in electronic format, (2) the notification that submitters will receive when FDA has received the electronic postmarketing safety report, and (3) procedures for requesting temporary waivers from the electronic submission requirement.
B. General Information About ICSR Submission
An ICSR is a description of an adverse drug experience related to an individual patient or subject. An ICSR is made up of data elements, such as date of adverse drug experience, name of suspect medical product, and name of manufacturer. These data elements are listed in the relevant regulations. The information described by the data elements should be included in the ICSR submission if available and applicable to the report.
ICSR attachments include supporting information for ICSRs, such as relevant hospital discharge summaries and autopsy reports or death certificates. ICSR attachments also include published articles for ICSRs based on scientific literature (§§ 314.80(d) and 600.80(d)).
C. Postmarketing Safety Reports Other Than ICSRs
For purposes of this discussion of electronic submissions, a postmarketing periodic report (§§ 314.80(c)(2) and 600.80(c)(2)) is considered to have three parts:
1. Descriptive information
2. ICSR(s)
3. ICSR attachment(s), if applicable
The descriptive information portion of the periodic adverse drug experience report (PADER) required under § 314.80(c)(2)(ii)(A) or periodic adverse experience report (PAER) required under § 600.80(c)(2)(ii)(A) should be submitted as a portable document format (PDF) file to section 5.3.6 of the Electronic Common Technical Document (eCTD). FDA is unable to accept submission of ICSRs to the eCTD because ICSRs submitted to the eCTD cannot be processed into the FAERS database.
D. Waiver Requests
Any person required to submit a postmarketing safety report under §§ 310.305, 314.80, 314.98, 314 600.80, 600.81, or section 760 of the FD&C Act may ask FDA to waive temporarily the requirement that the safety report be submitted in electronic format FDA anticipates that temporary waivers will be needed only in rare circumstances.