The Food and Drug Administration (FDA) recently finalized the guidance for post-market safety reports of biologics and drugs. The new FDA guidance “Providing Submissions in Electronic Format – Post-marketing Safety Report” was published in April 2022. This guidance will assist the industry when making regulatory submissions for the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
The following FDA provisions set the layout for this FDA Guidance document:
- 21 CFR 314.80 and 314.98 – New Drug Applications (NDA) and Abbreviated New Drug Application (ANDA)
- 21 CFR 600.80 – Products with approved biologics license applications (BLA)
- 21 CFR part 4, subpart B – Combination products with approved NDA, ANDA or BLAs
- 21 CFR 310.305 – Prescription drugs for human use with approved NDAs or ANDAs1
The new guidance lays out how Individual Case Safety Reports (ICRS) should be filed with the FDA after a safety alert has been initiated2. A Manufacturer can submit their reports electronically in two ways to the FDA. They can submit an ICRS through the electronic submission gateway or submit manually through the safety reporting portal. Both submission methods are available 24 hours a day, 7 days a week.
The guidance recommends a manufacturer should stay consistent with the submission method utilized to avoid duplicate reports and creating confusion in the agency. The FDA Adverse Event Reporting System (FAERS) electronic submission coordinators are available to assist with the submission of post-marketing safety reports2.
FDA safety reporting often involves the submission of a series of reports consisting of initial and follow-up Individual Case Safety Reports with associated attachments throughout the life cycle of the case. If your company needs assistance with submissions of post-marketing safety reports, EMMA International can assist. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.
1FDA (April 2022) Providing Submissions in Electronic Format — Post marketing Safety Reports Retrieved on May 1, 2022, from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-submissions-electronic-format-postmarketing-safety-reports
2RAPS (April 2022), FDA finalizes electronic post marketing safety reporting guidance Retrieved on May 1, 2022, from https://www.raps.org/news-and-articles/news-articles/2022/4/fda-finalizes-electronic-postmarketing-safety-report
