Drugs

ANDA Sameness Evaluation Guidance

FDA has published a guidance, Sameness Evaluations in an ANDA — Active Ingredients, to assist applicants in preparing an ANDA by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic product and its reference-listed drug. The document says FDA will refuse to approve an ANDA if it contains insufficient information to show that, among other things, the active ingredient of the proposed generic drug product is the same as that of the reference-listed drug.

“The ANDA applicant is responsible for providing sufficient information to demonstrate that the proposed generic drug product is the ‘same as’ the reference-listed drug with respect to the active ingredient,” the draft says. “FDA has broad discretion to determine whether an ANDA applicant has submitted information sufficient for the agency to reasonably conclude that the proposed generic drug product’s active ingredient is the same as the active ingredient of the reference-listed drug.”

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