Drugs

BLA Assessment Roles Clarified

CDER has issued a Manual of Policies and Procedures (MAPP) on the role of the Office of Biotechnology Products (OBP) and the Office of Process and Facilities (OPF) in assessing BLAs. The two offices are located within the Office of Pharmaceutical Quality. The MAPP says that OBP and OPF have implemented a process improvement initiative to improve coordination in the evaluation of applications. The initiative includes development of:

a timely and responsive system to ensure product quality throughout the product life cycle;
a process that allows for efficiency, consistency, and innovation within the agency and in industry;
the use of science-based risk management and quality principles; and
an integrated (multi-disciplined) collaboration.

The MAPP was created to outline OBP and OPF responsibilities and procedures as part of the process improvement initiative, it says.

The joint responsibilities of OBP and OPF include (1) quality assessment of BLAs in accordance with discipline-specific areas of responsibilities; and (2) planning and conducting collaborative establishment inspections to ensure safety, purity, and potency of the product based on the firm’s compliance history, the process control strategy, and facility information.

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