FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

A practical review of 505(b)(2) application requirements, reliance strategies, CMC expectations, product categories, and FDA approval pathway considerations.

Included with TalkFDA Subscription.

COURSE OVERVIEW & STRUCTURE

505(b)(2) depends on justified data reliance.

Regulatory teams must determine whether a product can appropriately rely on existing data while meeting FDA expectations for submission completeness. This session structures 505(b)(2) pathway requirements, application content, CMC expectations, approvable categories, product examples, and practical submission considerations.

The session reviews the 505(b)(2) pathway from eligibility and definitions through application contents, CMC requirements, product categories, and FDA review considerations. Discussion includes common misconceptions, examples of approved products, and practical points that influence pathway planning and submission preparation.

WHAT YOU’LL LEARN

Determining 505(b)(2) pathway suitability

Applicable 505(b)(2) regulations and definitions
Common misconceptions about data reliance
Product categories approvable under 505(b)(2)
Application content and submission requirements
CMC expectations for 505(b)(2) products
Examples of approved drugs and biologics
Important planning considerations
Recommended practices for pathway preparation

WHO SHOULD ATTEND

Designed for professionals involved in drug approval strategy, submission planning, quality review, or FDA regulatory pathway evaluation.

Regulatory Affairs

Quality Assurance

Clinical Affairs

Research Development

CMS & Drug Development

Compliance

FACULTY

Kelly Thomas

Kelly Thomas brings close to three decades of pharmaceutical and medical device industry experience across cGMP operations, quality systems, validation, and regulatory execution. Her background in process validation, product validation, CSV, Part 11, cleaning validation, and complex regulated projects supports a practical view of 505(b)(2) submission planning, CMC expectations, and approval pathway readiness.

AFTER YOU REGISTER

Everything related to your course lives in one place.

FDB3208

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After you register your seat, our team organizes everything for you; from access to certification – “from one place”.

You receive a confirmation and your course appears instantly in your TalkFDA dashboard.
Your course page becomes your central hub where you can join the session, access materials, and manage your learning.
At the scheduled time, simply click Join Session and you’ll be connected to the live Webex session with the instructor.
After the session, the playback becomes available on the same course page so you can revisit important sections.
Complete the course and your certificate is unlocked automatically in your learning history.

For Teams Seeking Deeper Implementation Support

Customized training is also available through

TalkFDA Elite Training Labs.

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

FDA Expectations for 505(b)(2) Regulatory Pathway for New Drugs

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