Department of Health and Human Services October 10, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs.'' This revised draft guidance supersedes the draft guidance entitled ``Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs,'' which was announced in the Federal Register on June 1, 2016. This revised draft guidance provides recommendations for the design and conduct of studies evaluating the adhesive performance of a transdermal or a topical delivery system (collectively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 clinical studies performed to evaluate TDS adhesion only or in clinical studies performed with a combined purpose (e.g., for the simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints). The recommendations in this revised draft guidance relate exclusively to studies submitted in support of an abbreviated new drug application (ANDA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), is withdrawing the notice published on September 17, 2018 to modify system of records No. 09-70-0541, titled ``Medicaid Statistical Information System (MSIS).'' The notice was prematurely published. A revised version will be published at a later date.