According to the document, they are:
>Bridging Strategies for presentation switches
- - Applicable data requirements
- - Application requirements
- - When are they required
- - Use in supporting promotional claims
- - Timing with respect to submission review, specifically, timing of labeling review by non-primary Centers
- - Guidance development
- - 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)
> 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Read the complete comments here: Comments on the Draft Guidance.
For your opportunity to discuss this draft guidance in depth with other professionals who have a stake in it's interpretation, join us at the Human Factors for Drug Device Combination Products event taking place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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