The general requirements for submitting BLAs, NDAs, and ANDAs are provided by the regulations in 21 CFR 314.50, 314.94, and 601.2. The section briefly addresses a few general problems related to supplying marketing applications in paper format. It ensures that we understand the expectations and terms related with Amendments and Supplements after the approval of product submission and then, as result of following the current PV statistical regulations, we have to make some changes.
A portion of the Technical Registration Document (TRD) and CTD documents on file in your facility is included in the initial submission. The FDA considers on a case by case basis, where it accepts submissions where some modules are provided in the TRD and CTD format, the format is not the exact same for the rest of the submission. Prior to ever submitting the final submission, it is always required to set up the NDA/BLA meetings with the FDA. It thus creates a more conducive environment for them to conceptualize and internalize their understanding of the whole process, which in turn ensures a smoother submission path and acceptance that allows the product to be marketed.
Attend this session by Jerry Dalfors, an expert with 40+ years of experience in the biopharmaceutical and medical device industry, to know about the ins and outs, the guidelines and challenges of regulatory submissions to the FDA. Jerry will review the needed documents and objective evidence that provides required detail to gain easy and quick approval of a product, by preparing a Common Technical Document (CTD) and the Technical Registration Document (TRD) for the registration of pharmaceuticals for human and veterinary use as the submission to the U.S. Food and Drug Administration (FDA).
He will also describe how to organize new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biological license applications (BLAs) based on the FDA expectations to approve the submission.
Who should attend?
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Dr. David Lim
Mr. Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.