Field Alert Reports – FDA Introduces the Automated Form 3331a

The Federal Food, Drug and Cosmetic Act, section 505(k) requires New Drug Application (NDA) holders to provide a Field Alert Report, on distributed drug product, to the Agency with any information concerning any incident that causes the drug product or its labeling to be mistaken for, or applied to another article, as well as information concerning any bacteriological contamination, significant chemical or physical changes, product deterioration, or failure of one or more distributed drug product batches to meet their respective specifications. The NDA/ANDA Field Alert reporting requirements, 21 CFR 314.81(b)(1)(i) and (ii), became effective on May 23, 1985. The regulation requires holders of NDAs and ANDAs “to submit certain information about distributed drug products” to the jurisdictional FDA district offices within three working days. The 3 working days begins when the applicant becomes aware of a reported problem through either a complaint or internal testing.

In May of 2013, FDA had launched a voluntary pilot program to modernize the FAR submission and review process by allowing firms to submit FARs electronically using an XML-enabled PDF form. This pilot project ended on June 15th, 2017 and FDA concluded that the use of the automated form “…improved the speed and efficiency of reporting on product quality issues related to the manufacture of drug products approved under a new drug application (NDA) or abbreviated new drug application (ANDA) by FDA.”

With the end of the pilot project on June 15, 2017, FDA is making a new version of the automated form—Form FDA 3331a—publicly available on its website (see FDA’s Field Alert Reports Web page ). The new version of Form FDA 3331a incorporates feedback from pilot project participants. FDA encourages all of industry to use this new automated form to submit FARs for both CDER and Center for Biologic Evaluation and Research (CBER) regulated drug products approved under an NDA or ANDA.

Form 3331a is part of FDA continuous efforts to improve the FAR submission process.  FDA is aware that the electronic Common Technical Document (eCTD) technical specifications for Module 1 include a section for FARs. FDA is currently working on the technical requirements for receiving FARs as part of the eCTD through the Electronic Submissions Gateway (ESG) and will provide additional information on this process in a future guidance.  At this time, FDA requests that firms do not submit FARs using the ESG, but instead follow the procedures provided on FDA’s Web page for using Form FDA 3331a.

 

For FAR reporting requirements related to NDAs and ANDAs, see 21 CFR 314.81(b)(1)

 

 

 

? For any questions or comments or your regulatory requirement please email to [email protected] or use our contact form.