Drugs

Additional GDUFA Resources Having Positive Impact: Analysis

FDA staff in the Office of Generic Drugs and Office of Biostatistics say their review of data collected in the third and fourth calendar years of GDUFA 1 shows a trend toward increased first-cycle approval of ANDAs. Writing in Therapeutic Innovation & Regulatory Science, the FDAers say the rate of first-cycle approval should continue over time as the agency’s communication efforts with industry improve ANDA completeness on submission. Ongoing issuance of product-specific guidances and other guidances also should continue to result in fewer deficiencies at the time of submission, they say.

The results showed that close to 25% of all ANDAs are not complete enough to allow FDA to perform a comprehensive review, the article says. Types of issues resulting in a refuse-to-receive response ranged from errors such as not providing English translation for portions of the application to absent or incomplete data on stability or dissolution.

After complete review by FDA, only a small percentage of ANDAs were approved or tentatively approved during the first cycle, the authors found. Some predictor variables were positively correlated with a successful first-cycle approval, including availability of product-specific guidance. The most common action for ANDAs in both calendar years was a complete response letter.

“Applicants should ensure that their ANDAs are complete at the time of filing and that their chemistry, manufacturing, and controls data, especially related to drug product, drug processing, and drug substance are addressed,” the article concludes.

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