Drugs

CGMP Violations at India’s Emcure Pharmaceuticals

A 1/27-2/4/15 FDA inspection at Emcure Pharmaceuticals, Maharashtra, India, found significant violations of current good manufacturing practices for finished pharmaceuticals. A 3/3 Warning Letter says that the violations included:
failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes; failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity; and failing to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards.

The letter provides detailed explanations under each of the three findings. Emcure was told to respond with a list of specific steps taken to correct and prevent the recurrence of the violations, with documentation that includes a third-party assessment of (1) comprehensive evaluation of the extent of the inaccuracy of recorded and reported data with a detailed action plan to fully investigate the extent of deficient documentation and data management practices; (2) a risk assessment of the potential effects of observed failures on the quality of the firm’s drug products; and (3) a management strategy for the firm that includes the details of its corrective action and preventive action plan.

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