Course Description -
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 FDA submission process course extremely useful.
Course Agenda
First Day
Legal Basis for FDA’s Authority to Regulate Chemical Drugs, Biologics and Biopharmaceuticals
- Overview of human medicine regulation by the FDA
- Drug regulatory pathways granted to the FDA by U.S. Congressional laws
- Human medicine distinctions: chemical drugs vs. biologics, CDER vs. CBER, generics vs. biosimilars
FDA Regulatory Drug Development Review and Approval Process
- FDA's requirements/expectations for CMC, Nonclinical, Clinical content from Phase 1 through market approval
- Differences in the FDA regulatory review and approval pathways for NDAs, BLAs, ANDAs and biosimilars
- Accelerated and fast track FDA review opportunities
Meeting with the FDA
- PDUFA, BsUFA, GDUFA meetings with the FDA - justified not entitled
- Risk assessment – when should you have a meeting with the FDA
- Lessons learned of what to do/not to do
Critical Importance of FDA Submissions and Communication during the IND Stage
- What the FDA is looking for in IND submissions/amendments – avoiding the 'clinical hold'
- Forms, format and content required during the clinical stages
- Strategic value of the End-of-Phase 2 (EOP2) meeting with the FDA
Second Day
Critical Importance of the FDA NDA/BLA/ANDA Dossier Preparation
- Need to avoid the Refusal to File
- What the FDA is looking for in the market application dossier – forms, format, content
- Strategic value of the Pre-NDA/BLA submission meeting with the FDA
FDA Review and Approval of the NDA/BLA/ANDA Submission
- First milestone – avoiding the 'Refusal to File'
- Intense interactions with the FDA covering CMC, Nonclinical and Clinical
- Race to meet the time clock – avoiding the Complete Response Letter
Post-market Approval Submissions and Interactions with the FDA
- Supplements for changes in CMC and Clinical, and required FDA reporting/updating
- Problem reporting: Field Alert Reports (FAR), Biologic Product Deviation Report (BPDR), and ORA inspections
- Honoring post-market approval commitments and ongoing adverse event reporting
Navigating the Rich FDA Website Resources
- On-line resources for Drugs
- On-line resources for Biologics
- Insights into the FDA NDA/BLA review process
Learning Objectives
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.
