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FDA EXPECTATIONS FOR 505(B)(2) REGULATORY PATHWAY FOR NEW DRUGS

This course strengthens the ability to assess whether drug and biologic products qualify for the FDA’s 505(b)(2) pathway while improving application planning, documentation alignment, and regulatory decision-making. It also clarifies common filing misconceptions that can delay approval progress. This Course is designed for professionals involved in drug development, regulatory submissions, quality oversight, and approval planning activities.

REGISTER FOR THE COURSE

US $190 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Kelly Thomas
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF3208
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

The FDA’s 505(b)(2) pathway provides a regulatory route for certain small molecule drugs and biologics by permitting applicants to rely partly on safety and effectiveness data from previously approved products. Determining whether a product qualifies under this pathway requires careful evaluation of existing investigations, application structure, and supporting documentation. Misunderstanding the pathway’s requirements can create avoidable submission deficiencies and delay approval timelines.


This TalkFDA Live webinar examines the FDA’s current expectations for 505(b)(2) applications, including applicable regulations, submission requirements, and content considerations. Attention is given to categories of products that may be approvable through this route, as well as chemistry, manufacturing, and controls expectations relevant to these applications. The session also addresses biologics transitioning under the Affordable Care Act and reviews examples of approved drug and injectable biologic products to clarify practical regulatory considerations.

  • Evaluate Product Eligibility and Submission Requirements:

    Participants will gain practical clarity on determining whether a product may qualify under the FDA’s 505(b)(2) pathway and how supporting investigations affect submission strategy. The course explains application content expectations, common misconceptions, and regulatory considerations that can influence review outcomes, particularly when relying on data from previously approved products.

  • Strengthen Regulatory Planning for Drug and Biologic Applications:

    The course provides focused understanding of FDA expectations for chemistry, manufacturing, and controls documentation within 505(b)(2) submissions, including considerations affecting certain biologics. Participants will better recognize operational and regulatory issues that can create approval delays, particularly as requirements evolve under the Affordable Care Act transition framework for applicable products.

Key Areas Covered

  • FDA regulations and core definitions associated with the 505(b)(2) regulatory pathway
  • Common misconceptions affecting eligibility assessments and submission planning
  • Categories of drugs and biologics potentially approvable under 505(b)(2)
  • Requirements for demonstrating reliance on investigations not conducted by or for the applicant
  • Application content expectations, including CMC requirements under 505(b)(2)
  • Drug and injectable biologic examples approved through the 505(b)(2) pathway
  • Important considerations involving biologics transitioning under 351(k) of the Affordable Care Act
  • Recommended practices and submission approaches aligned with current FDA expectations

Who Must Attend

  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • Clinical Affairs Departments
  • Research and Development Departments
  • Consultants

Quality training, expert insights, and answers that matter. Know your Expert

KELLY THOMAS 

Ms. Thomas has more than twenty years of pharmaceutical and medical device industry experience involving cGMP operations, quality systems, and validation activities relevant to regulated product development and manufacturing. Her background includes process and product validation, facilities validation, computerized systems validation, 21 CFR Part 11 compliance, equipment qualification, and cleaning validation. Her experience applying risk-based approaches and managing complex operational projects supports practical discussion of regulatory expectations and submission-related considerations affecting 505(b)(2) applications.

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Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

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Your organization deserves the confidence.

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1. Confirmation
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2. Your Course Hub
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3. Access course materials
The presentation handout and other materials can be downloaded inside the Course Player. You could use Discussion feature there to ask your questions.

4. Watch The Streaming and Complete your Course
The course playback will be available on the same course page. You could pause and continue or you can revisit important sections.
5. Earn Your Certificate
Complete the course and your certificate is unlocked automatically in your learning history.

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Our students love us ❤️

“Content moved at a steady pace and covered the important areas well.”


Lead, Research and Development

“Session stayed relevant to current industry practices and submission concerns.”


Director, Compliance Affairs

“Didn’t feel like a generic training. There was some thought behind how it was built.”


Manager, Quality Assurance

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