Drugs

CDER Research on Transdermal Generic Evaluations

A new FDA post discusses research by CDER statisticians who developed innovative and more efficient ways to evaluate transdermal and topical delivery systems (collectively called TDS). Instead of evaluating similarity of adhesion between test and reference scores as the ratio of means (ROM) adhesion scores, CDER statisticians settled for a comparison based on the difference of mean (DOM) adhesion scores. “As opposed to the previous noninferiority threshold of a test/reference ratio of less than 1.25, CDER experts determined that the more appropriate noninferiority threshold would be based on the difference in the test product and reference product overall mean adhesion scores, with a noninferiority margin of 0.15 (i.e., 15%),” the post says.

“Computer simulations were conducted to compare the power of the two approaches (ROM vs. DOM) while varying critical parameters such as study size (number of subjects) and variability (e.g., across adhesion scores in a given subject) for a range of different test and reference product adhesion scores (i.e., for TDS spanning the range from well adhering to poorly adhering),” the agency says. “These simulations demonstrated that the low power of the traditional ROM approach was due to the (numerically) small values of the scores for well adhering brand name (reference) products. These investigations showed that the DOM approach would provide much higher power to correctly conclude that well-adhering test products exhibited noninferior adhesion compared to a well-adhering reference product, without increasing the probability of mistakenly concluding that a poorly adhering test product showed acceptable, noninferior adhesion (i.e., Type 1 error was controlled at the same level).”

The research resulted in a new draft guidance for industry that recommends using the more powerful DOM method rather than the previous ROM method for the statistical noninferiority analysis when comparing the adhesion performance of a would-be generic TDS to its corresponding reference product. To determine how well the DOM approach would work with real world data, CDER statisticians looked at 40 studies comparing the adhesion of test and reference TDS products that had been submitted to the FDA in applications for generic TDS products and applied the updated recommendations in the new draft guidance, the post says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome