On June 10, 2014, FDA published a final rule in the Federal Register, titled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements.” Among many things, this rule states that “certain postmarketing safety reports… be submitted to FDA in an electronic format that the Agency can process, review, and archive.” The rule and the many requirements within, will go into effect in just a few short weeks on September 8, 2015, giving vaccine makers more than a year to comply after the announcement was made.
With the new rule in place, the Agency announced a draft guidance, titled “Providing Submissions in Electronic Format—Postmarketing Safety Reports for Vaccines,” on July 18, 2014.
Last week, FDA announced the availability of the final guidance (“Providing Submissions in Electronic Format—Postmarketing Safety Reports for Vaccines”) regarding making postmarket regulatory submissions to CBER in electronic format. The guidance is one in a series of documents, and is intended to establish a set of procedures and best practices for submitting vaccine safety reports.
So, what is the difference between this guidance and the rule that will go into effect in just two weeks? The major difference is that the guidance is focused solely on vaccine products, and the rule applies to postmarket safety reports for both drugs & biological products.
Intended to assist applicants, the guidance includes information and recommendations regarding the e-submission of Individual Case Safety Reports (ICSRs) and attachments to ICSRs into the Vaccine Adverse Event Reporting System (VAERS). In addition, it applies only to vaccines marketed with approved BLAs that are regulated by CBER.
The guidance, which defines ICSR as “a description of an adverse experience related to an individual patient or subject that is associated with the use of a vaccine product,” goes on to state that there are three types of ICSR submissions, including:
The guidance provides the following “general information related to electronic submission”:
In addition, the guidance also includes information regarding requests to temporarily waive the requirement that the safety report be submitted electronically. These waiver requests will only be needed in rare circumstances, which FDA states as “acts of nature, widespread internet outages, temporary issues with the applicant’s adverse event database(s)”, etc. and will not be grated to companies experiencing technical difficulties submitting their application of their electronically. (For more information, view the full guidance here.)
With the compliance date just a few weeks away we’re really getting down to crunch time! We know how difficult it can be to try and make sure you are compliant with FDA regulations on your own, and that is why we are here to help! Combining extensive scientific knowledge with a deep understanding of the regulatory environment, our unique approach has helped a number of our clients obtain a successful outcome with FDA. For more information about how we can help you ensure compliance, contact us!
But, wait… That’s not all! We can also help with the contents of your application! Learn more about our services here and contact us to learn how we can provide assistance to your company, specifically!
August 27, 2015
On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...
August 27, 2015
On Friday, October 30, 2015, FDA released a draft guidance, entitled “Bioequivalence Recommendations for Progesterone,” in which the Agency offers product specific guidance on the design of...