Drugs

‘Refuse to File’ Policy MAPP

CDER has published a Manual of Policies and Procedures. Good Review Practice: Refuse to File, outlining the policies, responsibilities, and procedures for the Office of New Drugs to follow to determine whether there is a basis to refuse to file (RTF) an NDA, sNDA, BLA, or sBLA submitted to CDER. The document says the MAPP is consistent with existing policies and procedures contained within appropriate sections and resources highlighted in the 21^st Century Review process and its accompanying Desk Reference Guide, and is intended to provide additional clarification about the refuse-to-file process.

“RTF is an important regulatory tool to help CDER avoid unnecessary review of incomplete applications or certain applications that are submitted as an NDA but should have been submitted as an ANDA,” the MAPP says. “Incomplete applications could lead to multiple-cycle reviews and inefficient use of CDER resources. CDER also believes an RTF action can allow an applicant to begin repair of critical deficiencies in the application far sooner than if these were identified much later in a complete response action and may lead to more rapid approval of safe and effective drug products.”

The document lists the reasons under regulations that describe the circumstances under which CDER may refuse to file an NDA or BLA application.

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