Drugs

GDUFA Completeness Assessment Guidance Out

FDA has issued a guidance, Completeness Assessment for Type 11 API DMFs Under GDUFA, to explain to holders of Type II active pharmaceutical ingredient drug master files (DMFs) that are or will be referenced in an ANDA, amendment to an ANDA, PSA to an ANDA, or a PSA amendment, requirements imposed as of 10/1/12 under GDUFA. Under the legislation, the document says, DMF holders are required to pay a DMF fee when first authorizing the reference of their DMF in a generic application, and Type II API DMFs must undergo an FDA completeness assessment (CA).

The guidance makes recommendations about the information that should be included in the DMF to facilitate a GDUFA CA. It does not apply to Type II API DMFs used to support NDAs, BLAs, other submissions that are not generic drug submissions, or any other types of DMFs.

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