Drugs

Guide on ANDA Facility Readiness and Goal Dates

FDA has released a draft guidance entitled “Facility Readiness: Goal Date Decisions Under GDUFA.” Under the new generic drug user fee agreement, which went into effect 10/1, the agency modified its procedures to incorporate facility readiness in review action goal date assignments, according to the document. In cases when one or more facilities are not ready for inspection, FDA says it will assign a 15-month goal date and defer substantive assessment of the original ANDA and any unsolicited amendments until receipt of an amendment with an updated Form FDA 356h stating all facilities are ready for inspection.

“Upon receipt of an amendment with Form FDA 356h certifying that all facilities are ready for inspection, FDA will reassign the appropriate standard or priority goal date (as applicable) calculated from the amendment receipt date,” the guidance says. “To facilitate goal date reassignment, FDA recommends the applicant state in the cover letter ‘Facility Ready For Inspection’ along with the ANDA number.

If applicants fail to submit an amendment with Form FDA 356h certifying all facilities are ready for inspection by 30 days before the goal date, FDA resets the goal date for an additional 15 months and begins its substantive assessment. “FDA agreed to assess and act on 90% of such ANDAs within 30 months of the date of the original submission as applicable,” the guidance 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