Friday, March 29, 2013

CPC Injector Systems Working Group: Comments on the FDA Draft Guidance

Yesterday, we looked at the Human Factors session that will help you interpret the draft guidance recently put forth by the FDA.  The CPC Injector Systems Working Group has taken the time to set out several of the key issues they have with this draft guidance.

According to the document, they are:

>Bridging Strategies for presentation switches
  • - Applicable data requirements
  • - Application requirements
> Human Factors Studies
  • - When are they required
  • - Use in supporting promotional claims
 >Coordination between centers
  • - Timing with respect to submission review, specifically, timing of labeling review  by non-primary Centers
  • - Guidance development
> Submission requirements
  • - Post-approval changes to combination products
  • - Evaluation of submission types for generic drugs marketed in an injector (e.g., 505(b)(1) vs. 505(b)(2) vs. ANDA)
 > Consistency between FDA’s Technical Guidance for Injectors and ISO standards including the 11608 series> Analytical release testing requirements for the combination product (e.g., functional testing requirements)

> Consistent application of FDA and ICH guidance allowing fulfillment of chemical/drug stability requirements of “bare” container closure when injector/device does not provide additional protection.

Read the complete comments here: Comments on the Draft Guidance.

For your opportunity to discuss this draft guidance in depth with other professionals who have a stake in it's interpretation, join us at the Human Factors for Drug Device Combination Products event taking place May 14-15, 2013 in Bethesda, Maryland.   Download the brochure to find out more about the session Interpretation and Clarification of the Guidance Document – What Constitutes Human Factors Engineering Success in the Regulator’s Perspective? and the rest of the program.  As a reader of this blog when you register to join us, mention code FF13JP and save 20% off the standard rate! 

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