Drugs

FDA Revamping NDA/BLA Information Requests

FDA is seeking public comments on a “Statement of Work” mandated by the recent drug user fee reauthorization to assess communication between the agency and sponsors through product quality information requests (IR) during NDA/BLA reviews, and to identify best practices and areas of improvement. The independent assessment will also examine the agency’s compliance with the application of “Four-Part Harmony” in product quality IRs, in which reviewers are expected to communicate:

what was provided;
the issue or deficiency;
what is needed; and
why it is needed.

The goals of the assessment are articulated in a document entitled Prescription Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2023 through 2027 (“PDUFA VII”) (page 48). For example, by the end of FY 2023, FDA says it will update and conduct training on CDER MAPP 5016.8, “Communication Guidelines for Quality-Related Information Request and Deficiencies” and CBER SOPP 8401.1, “Issuance of and Review of Responses to Information Request Communications to Pending Applications” describing the guidelines for the content of information requests. The updates and training are intended to promote FDA reviewers’ use of Four-Part Harmony, the performance goals document says.

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