Drugs

FDA Expanding Electronic Import Communication System

FDA is planning a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) account management function. Currently, ITACS provides the import trade community with four functions: (1) The ability to check the status of FDA-regulated entries and lines, (2) the ability to submit entry documentation electronically, (3) the ability to electronically submit the location of goods availability for those lines targeted for FDA physical examination, and (4) the ability to check the estimated laboratory analysis completion dates. No user login accounts are necessary to access these functions at this time, and the pilot intends test a “user account management function” that would require the user login accounts, according to an FDA notice.

User login accounts would allow FDA to distribute “Notices of FDA Action” to users electronically via email rather than regular mail, and enable users to download such notices from within ITACS. User login accounts would also allow users to view in ITACS the details of specific information requests, which are currently delivered via hard copy Notices of FDA Action, the agency says. Additionally, the accounts would allow for “potential future ITACS enhancements, requested by the import trade community, that require user authentication,” it 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