Biologics

4 CBER SOPPs on Application Processing

CBER has published four Standard Operating Policies and Procedures (SOPPs) relating to the administrative processing of applications. SOPP 8401: Administrative Processing of Original BLAs and NDAs includes those subject to the Biosimilar User Fee Act (BsUFA) and Prescription Drug User Fee Act (PDUFA). It does not apply to BLAs subject to the Medical Device User Fee Act (MDUFA), ANDAs subject to the Generic Drug User Fee Act (GDUFA), or annual reports.

SOPP 8401.1: Issuance of and Review of Responses to Information Request Communications to Pending Applications applies to BLAs, ANDAs, medical device applications, and their respective amendments and supplements. It applies to products covered by BsUFA, GDUFA, MDUFA, and PDUFA and non-user fee products in these product categories.

SOPP 8401.2: Administrative Processing of BLA and NDA Supplements applies to supplements processed by CBER including those subject to PDUFA and BsUFA. It does not apply to supplements for medical device BLAs or those subject to GDUFA.

SOPP 8401.4: Review Responsibilities for the CMC Section of Biologic License Applications, New Drug Applications, and Supplements does not address review responsibilities for PMAs, licensed (BLA) in vitro diagnostics, or blood and blood components intended for transfusion and for further manufacturing that are reviewed by the Division of Blood Components and Devices/Office of Blood Research and Review.

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