|Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.
Training Program: Pharmaceutical Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA
Training Provided By: BioPharma Institute
Availability: Immediately available upon ordering.
Description: Online training with immediate access upon enrollment. This course describes FDA expectations of applications for the licensing of generic products. It provides the background knowledge to effectively plan, gather and assemble the necessary documentation for the submission of an Abbreviated New Drug Application (ANDA). Practical advice in the form of checklists is provided, and timelines are set out. The ANDA process is compared and contrasted with that for the NDA.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.
Online Training Programs Include:
The Pharmaceutical Regulatory Affairs: The ANDA: Requirements for Obtaining FDA Approval for a Generic Product in the USA course is found in the following professional certification program(s):
Regulatory overview: course scope and objectives, areas not covered, and the US legislative framework.
Students completing this course should be able to: Outline the FDA generic drug approval system. Describe the differences between the generic drug approval process and the new drug approval process. Identify information contained in the -Orange Book-. Describe the methodology for determining bioequivalence of drug products. Explain how to develop and submit a successful ANDA.
For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.