Drugs

Consolidate Alternative Inspection Guidances: PhRMA

FDA should consolidate its recent draft guidance on “Remote Interactive Evaluations (RIE) of Drug Manufacturing and Bioresearch Monitoring Facilities” with similar draft guidances due to an overlap in content and to minimize confusion. In comments submitted to FDA, Pharmaceutical Research and Manufacturers of America (PhRMA) says the RIE guidance should be consolidated with draft guidances: (1) Conducting Remote Regulatory Assessments Questions and Answers; and (2) Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications.

PhRMA’s comments also urge FDA to update the guidance to “explicitly affirm that the agency will consider inspection findings consistent with existing Mutual Recognition Agreements (MRAs) in determining when and whether to utilize an RIE. Further, we recommend FDA add a sentence to the draft guidance confirming that any materials collected or reviewed in the course of an RIE are protected in a similar manner as materials collected during on-site inspections under FOIA.”

Additionally, PhRMA says FDA should revise the guidance to stipulate that:

FDA provide at least three weeks advance notice of any planned RIE when feasible
FDA explicitly inform the facility whether the agency intends to request video recordings or live camera viewings as part of the RIE
FDA notify firms if it expects certain manufacturing operations to be ongoing at the time of the RIE
FDA provide details on how it intends to formally acknowledge the closure of an RIE, including expected timelines

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