This course will give participants the necessary overview of the US Food and Drug Administration's (FDA) current responsibilities, procedures, guidances and regulatory pathways that affect the review and approval of chemical drugs, biologicals, biopharmaceuticals, biosimilars and chemical generics. Using the ICH Common Technical Document (CTD) module format outline, significant Chemistry Manufacturing and Controls (CMC), Nonclinical and Clinical areas will be analyzed and discussed, as a basis for strategic planning for both submitting INDs, NDAs, BLAs, ANDAs, and post-approval supplements, as well as for holding key meetings with the FDA.
Similarities and differences between clinical INDs and market approval dossiers, and between the various market approval dossiers (NDAs, BLAs, and ANDAs) will be discussed. Other topics to be discussed include Fast Track pathway, comparison of chemical generics with biosimilars, FDA's commitments under the User Fee Acts (PDUFA, BsUFA, GDUFA) and FDA's evaluation of industry's performance in meeting its requirements and expectations for review of drug products.
Who Should Attend
Personnel in the pharmaceutical, biopharmaceutical, biologics and generic drug industry who are involved in preparing FDA submissions (INDs, NDAs, BLAs, ANDAs, post-approval supplements) will find this course to be of particular benefit. Those who need to interact with FDA staff, including Project Managers, Regulatory Affairs, Clinical, Nonclinical, Manufacturing, and Quality personnel, will also find this course extremely useful.
By the end of this course, attendees will:
- Understand the importance and underlying principles of the FDA regulatory review process for chemical drugs, biologics and biopharmaceuticals from Phase 1 IND through market approval
- Learn how to prepare appropriate and necessary FDA regulatory submissions throughout the drug development process covering the CMC, Nonclinical and Clinical areas
- Learn how to more effectively communicate with the FDA through submissions and meetings
- Fully understand the seriousness with which the FDA carries out its responsibilities and the ramifications of either not filing or filing incomplete submissions
Frequently Asked Questions
How much of the course deals with NDAs and how much with INDs?
The course discusses all the ICH requirements for the CMC section of NDAs, i.e., Module 3 and the Quality Section of Module 2. This provides participants who are working on NDAs with a detailed outline from which to construct an NDA. For participants who are working on INDs, the course provides the scope of studies that will be needed to prepare an NDA and a discussion of the reduced requirements for each Module 3 section for INDs in Phase 1, 2 and 3.
Does the course cover biologics and ANDAs?
The course does not cover the information and data required for filing a biologically produced active ingredient to be filed with CBER nor specific requirements for ANDAs.
Does the course cover post-approval changes?
The course addresses submission of Comparability Protocols for post-approval changes but not other guidances related to post-approval changes.
I am new to CMC and regulatory affairs. Will I understand what is being presented?
The course covers the requirements for NDAs and INDs in a very systematic way and provides a complete overview so it is a good introduction to this field.
I have filed several NDAs already. Will I get anything out of the class?
Participants with experience filing NDAs have found the course valuable in assessing whether they are filing too much or too little information and data.