Drugs

Better Communications Needed for Faster ANDA Approvals

A Lachman Consultants blog post says that both FDA and industry realize that the only real way to cut down on FDA’s ANDA review workload is to get it right the first time. “Industry continues to say with the constantly changing requirements and FDA expectations, it makes this very difficult to achieve,” the post continues. “The agency complains about the quality of ANDA submissions and wants firms to up their game.”

With 1,000 to 1,200 ANDA submissions expected this year, it’s important that both sides work together toward timely approvals and reduction of workload, Lachman’s Bob Pollock writes. “The communications cannot continually be in the form of Complete Response Letters and Easily Correctible Deficiencies communications,” he writes. “More effort on communication, such as telephone conversations like the old telephone amendment, with appropriate documentation could bring an application to approval stage in a more efficient manner with a faster result. While this might not be appropriate for all ANDAs, those that need simple clarification or where minor issues may need to be addressed would benefit from such interactions that are, of course, properly documented.”

Pollock says that looking at best practices from the PDUFA program and what FDA has learned from GDUFA shows that early communication before issuance of formal written communications may well be the best and most efficient way to handle some of the review issues. “FDA has agreed to take a fresh look at applying such communication strategies to the review of ANDAs to increase first cycle approval rates (which now stand at about 8-9%),” the post concludes. “This effort will be welcome by the industry, and serve to boost first cycle reviews. The (unfortunate) dilemma is that, from the time the ANDA is submitted until it is picked up for review, there may be changes in expectations or requirements. Bringing these issues to the attention of the sponsor very early in the review process will hopefully help both FDA and industry achieve an improvement in the rate of first cycle approvals.”

Gupta Raises Concerns About Overton’s Independence, Ideology

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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