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.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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 INDs and how much with NDAs/BLAs?
The course covers all aspects of FDA submissions and communicating with the FDA; all the way from submission of the original IND, through IND amendments, FDA meetings during clinical development, preparation and submission of the market approval dossier (NDA, BLA, ANDA) and maintenance of the market approval.
Does the course cover CMC, Nonclinical and Clinical concerns?
The course covers FDA concerns and expectations for Chemistry, Manufacturing & Control (CMC), Nonclincal (i.e., animal studies) and Clinical (i.e., human studies).
I am new to regulatory issues. Will I understand what is being presented?
The course systematically covers all aspects of FDA submissions and communications in three layers. The first layer is a broad overview, and the remaining two layers each dig deeper into understanding the FDA concerns.