Drugs

Inactive Ingredient Database Suggestions

The Association for Accessible Medicines suggests that FDA include additional details concerning expected justification content when referencing an Inactive Ingredient Database (IID) listing that differs from the proposed excipient in nomenclature, molecular weight, viscosity, or grade. The group made the suggestion in its comment to an FDA draft guidance on using the IID. The association also notes that since the IID is updated quarterly, the timing of an ANDA could be in jeopardy, and recommends that the agency provide further detail on the receipt of an application when excipient usage was previously guided by a previous version of the IID.

The group also raises concerns about the accuracy and integrity of information in the IID since inconsistencies with respect to the maximum potency per unit dose have been frequently observed across different IID versions.

In its letter, AbbVie identified several potential enhancements to the IID for FDA to consider, including extending the scope of the guidance to include BLAs managed under CDER and including the excipient information reported in CDER-led BLAs within the scope of the IID. It also recommends adding specific information on different grades of excipients to the IID and updating the guidance to address how the same excipient with different grades will be managed in the IID.

Apotex submitted line-by-line technical comments.

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