Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs Draft Guidance for Industry October 2018
Not for implementation. Contains non-binding recommendations.
- Docket Number:
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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The recommendations in this guidance relate exclusively to studies submitted in support of an abbreviated new drug application (ANDA). This guidance provides recommendations for the design and conduct of studies evaluating the adhesive performance of a transdermal or topical delivery system (collectively referred to as TDS). Depending on the objectives of a TDS product development program, applicants may choose to evaluate TDS adhesion in studies performed to evaluate TDS adhesion only or in studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints).
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2016-D-1254.