Biologics

CBER Updates Refusal-to-File Procedure

CBER has released an updated standard operating policy and procedure (SOPP) manual entitled “SOPP 8404: Refusal to File (RTF) Procedures” that has updated RTF examples and an updated Appendix A that lists examples of easily correctible deficiencies.

According to the document, RTF decisions may be made based on findings such as:

Administrative incompleteness, e.g., clear omission of information or sections of required information.
Scientific incompleteness, such as omission of critical data, information or analyses needed to evaluate safety, purity and potency or provide adequate directions for use, including clinical information, quality, manufacturing, and facility information, pharmacology/toxicology information and/or critical statistical analyses or the analysis of a study as planned in the protocol (as opposed to a different, post-hoc analysis).
Inadequate content, presentation, or organization of information such that substantive and meaningful review is precluded, such as illegibility, failure to translate portions of the application into English, data tabulations (line listings) or graphical displays that are uninterpretable, failure to reference the location of individual data and records in summary reports; absence of protocols for clinical trials.

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