Drugs

Meeting the 510(j)(3) Reporting Requirement

Two Wiley Rein attorneys say a proposed FDA requirement to report the amount of listed drugs and biological products under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act represents a big change for many companies that have not had to report distribution data to the agency. A recent draft guidance is to help registrants of drug establishments comply with the responsibility to annually report on the amount of each listed drug manufactured, prepared, propagated, compounded, or processes for commercial distribution. The requirement was added by the CARES Act to enhance FDA’s ability to identify, prevent, and mitigate potential drug shortages.

In an online post, the attorneys review the guidance’s contents and suggest that companies review their internal systems to determine if there are opportunities to leverage pre-existing data to generate the new section 510(j)(3) report and thus alleviate some of the burden.

“For instance,” the attorneys write, “given the reported amount concerns only each listed drug that was released during the reported year, companies may want to create a cross-functional working group comprised of the quality control unit, technical operations, regulatory/compliance, and finance/accounting departments. In our experience, these groups house a significant amount of relevant information that can be utilized and cross-checked to ensure the section 510(j)(3) report’s accuracy.”

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