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Waiver Requests

Waiver Requests. Ken Harshman, MS, DVM April 2011. What needs to be included?.

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Waiver Requests

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  1. Waiver Requests Ken Harshman, MS, DVM April 2011

  2. What needs to be included? • Form FDA 356v – this is a new requirement because if the information included in a waiver is accepted and we granted a waiver from the requirement to conduct in vivo bioequivalence. If you are granted a waiver, this information now supports your approval and CVM requires a 356v for information that supports an approval.

  3. What needs to be included? • Identify: • Proprietary name for the proposed generic new animal drug (if known) & the reference listed new animal drug (RLNAD) • Established names for both • The strengths, dosage form, and route of administration for the proposed generic and approved for the RLNAD • The indications for the proposed generic and approved for the RLNAD • The sponsor and NADA No. for the RLNAD • The species proposed for the generic and approved for the RLNAD

  4. What needs to be included? • Certificates of analysis for all of the components of your product (including information on the specifications used, e.g., USP,NF, EP, etc.) • A side by side comparison of generic and RLNAD formulations - • Formulations should contain same ingredients/same concentration (Q1/Q2) • If differences exist, provide justification/evidence that these differences will not affect bioequivalence • A justification for why your product should be granted a waiver • Patent and Exclusivity Information • Current labeling for the RLNAD • Draft or representative generic labeling

  5. Q1/Q2 is about sameness

  6. What needs to be included? • Qualitative (Q1) sameness • Contains the same inactive ingredients as the RLNAD • Quantitative (Q2) sameness • Concentration or amount of each of the inactive ingredients differs by no more than 5% of the corresponding ingredient in the RLNAD

  7. What needs to be included? • Any change in formulation can not affect absorption or availability of the active ingredient • Consider reverse engineering (deformulating) the RLNAD

  8. What needs to be included? • If applicable, the following as well: • pH range of generic product • Particle size of active ingredients • Presence and significance of polymorphs or entantiomers of the active ingredients

  9. What needs to be included? • Solubility data • Exception – If you are seeking a waiver for a soluble powder oral dosage form, you may include a statement making a commitment to meet solubility requirements for demonstrating bioequivalence as part of your CMC technical section. In that case, you do not have to provide solubility information in your waiver request. • Solubility data needed to fulfill a biowaiver request and that required to complete the CMC technical section for soluble oral dosage forms are identical and obtained by the same methods.

  10. New BE Policy • A non-aqueous solution or micellular solution could qualify for a biowaiver • Will be evaluated on a case-by-case basis • Requirements • Q1/Q2 • Additional characterization of physico-chemical properties, if requested • In vitro testing, if requested

  11. Common mistakes to avoid • Failure to justify how differences in the formulation do not adversely affect the bioequivalence of the generic product • Incomplete characterization of the proposed generic formulation • No side-by-side comparison of formulations • Improper identification of the RLNAD

  12. Questions?

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