FDA publishes new recommendations for industry regarding Transdermal and Topical Delivery Systems for ANDAs

On October 9, 2018, the FDA published notice of two draft guidances and 25 individual product-specific guidances related to the design and conduct of studies for evaluating transdermal and topical delivery systems (TDS) submitted in supported of Abbreviated New Drug Applications (ANDAs). As outlined in the agency’s Drug Competition Action Plan, the FDA is committed to providing scientific and regulatory clarity for sponsors seeking to develop complex generic drugs. The FDA is publishing this collective update of its recommendations on transdermal delivery system studies to provide clear, convenient information to current and potential ANDA applicants. 

The FDA believes that the increased transparency provided by general and product-specific guidances gives applicants seeking to develop generic copies of complex drugs a better opportunity to efficiently allocate resources and prepare better/more complete submissions. The agency works to make sure that its policies and regulations reflect evolving science to facilitate the submission and approval of generic versions of these complex products so that patients have access to affordable medicines. Greater access to high quality generic drugs is key to advancing the public health.

These publications, which apply to TDS products submitted in ANDAs, include the following:

• The revised draft guidance for industry, Assessing Adhesion with Transdermal and Topical Delivery Systems for ANDAs, provides updated recommendations for the design and conduct of studies evaluating the adhesive performance of a transdermal or topical delivery system (TDS) submitted in support of an ANDA. 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). The recommendations in this revised draft guidance relate exclusively to studies submitted in support of an ANDA. This revised draft guidance supersedes the draft guidance entitled “Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs,” which was published in June 2016. The FDA recommends that applicants consult the revised draft guidance in conjunction with any relevant product-specific guidances for industry when considering the design and conduct of other studies that may be appropriate to support the BE of a proposed generic TDS drug product to its reference listed drug (RLD) and/or reference standard (RS) product. To comment on the draft guidance, please visit the public docket, FDA-2016-D-1254. 

• The draft guidance for industry, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs, provides recommendations for the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a transdermal or topical delivery system (TDS). The recommendations in this draft guidance relate exclusively to studies submitted in support of an ANDA. The FDA recommends that applicants consult this draft guidance in conjunction with any relevant product-specific guidances that contain product-specific recommendations (1) for their I/S study or (2) for other in vivo studies that may be necessary to establish the bioequivalence of a proposed generic TDS drug product to its reference listed drug (RLD) and/or reference standard (RS) product. To comment on the draft guidance, please visit the public docket, FDA-2018-D-3546.

• 25 product-specific guidances, including 2 new and 23 revised guidances, that, when finalized, will describe the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA recommends that applicants consult the relevant product-specific guidance, in conjunction with the guidances referenced above, when considering the design and conduct of studies that may be appropriate to support a TDS product intended for submission in an ANDA. To comment on these product-specific recommendations, please visit the public docket, FDA-2007-D-0369.