Drugs

FDA Nixes Additional Risk-based BE Testing Actions

FDA has denied in part a Therapeutic Proteins International petition asking that it take actions to advance the use of risk-based bioequivalence testing. To the extent that the petition asks the agency to undertake activities it is already doing, the letter says, it is granted.

The 2007 petition called on FDA to request comments on how modifications to dissolution testing can be used to substitute bioequivalence. It also said it wanted the agency to invite comments on the creation of novel dissolution systems that can be used to establish bioequivalence for all products where thermodynamic activity is feasible. FDA says it appeared that the petitioner thought such information was necessary to permit establishment of “risk-based bioequivalence testing.” The petition also said that risk-based testing is necessary because the protocols that have been used for bioequivalence testing are “based on assumptions that are no longer considered valid scientifically.”

The agency says it disagrees with the notion that the use of in vivo blood tests to establish bioequivalence is not scientifically valid. It also notes that for certain drug products, a traditional in vivo bioequivalence study comparing the rate and extent of absorption of the active ingredient into the bloodstream is of limited value. Thus, it says, publishing product-specific recommendations enables FDA to make recommendations about appropriate bioequivalence study designs on a case-by-case basis considering available information and provides the public with an opportunity to comment.

“We believe that the current system of publishing product-specific recommendations for generic drug development, in conjunction with our other efforts to obtain public input on and disseminate our current thinking on bioequivalence testing methodologies, is largely responsive to your request that we ‘open comment’ on novel dissolution tests that can be used to establish bioequivalence,” the letter concludes…. “Therefore your petition is granted to the extent that it asks us to open comment on novel dissolution tests that can be used to establish bioequivalence. To the extent that your petition asks us to undertake additional activities, it is denied.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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