Drugs

CGMP Deviations at Bioiberica

A 1/31-2/4 FDA inspection at the Bioiberica, SAU, drug manufacturing facility in Barcelona, Spain, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 6/30 Warning Letter says specific deviations were:

failing to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of the company’s intermediates and API; and
failing to ensure that reworked batches have been subjected to appropriate evaluation and stability testing to ensure that the reworked material is of equivalent quality to that produced by the original process.

The letter also says that Bioiberica does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality. Based on the nature of the deviations identified at the firm, FDA strongly recommends that the company retain a qualified consultant to assist it in meeting CGMP requirements.

Bioiberica was told to respond with a list of specific steps it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrective actions.

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

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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