FDA Issues New Flurry of Trial-Related Guidances

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The U.S. Food and Drug Administration (FDA) has continued its torrid pace by releasing a slew of new clinical trial guidances over the past few weeks.

New guidances include a revised draft guidance on Assessing Adhesion with Transdermal and Topical Delivery Systems [TDS] for ANDAs, which provides updated advice for the design and conduct of studies evaluating the adhesive performance of a proposed generic TDS, FDA Commissioner Scott Gottlieb, MD, said when announcing the latest actions.

A second draft guidance, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs, provides recommendations for the design and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 potential of a proposed generic TDS.

In addition to these documents, the FDA is issuing 25 product-specific guidance documents. These include two new and 23 revised guidances. These documents will support industry in identifying appropriate, science-based methodologies and evidence for developing generic TDS products.

“In too many cases, there is no generic competition for these costly, branded drugs even after they have lost their exclusivity protections,” Gottlieb said. “We have made a new commitment to develop product-specific guidance documents laying out how to develop a generic copy of a branded medicine for any currently marketed, branded complex medicine in an effort to advance a more efficient and effective framework for developing generic copies of complex drugs.”

Gottlieb gave industry a heads-up that more action is on the way, saying “We will strive to release each document as soon as scientific recommendations can be developed.”

In other FDA guidance action, the agency said in a new guidance released yesterday that it may accept safety analyses drawn and projected out from pooled clinical trial data as long as sponsors have carefully planned their evaluations and are willing to show their work.

“Our goal is to encourage more pooled studies to evaluate important safety events,” Gottlieb said.

Author: Michael Causey