Drugs

FDA-483 on IntegraDose Inspection

FDA has released the form FDA-483 issued following a 7/15-7/25 inspection at IntegraDose Compounding Services, a Minneapolis, MN, outsourcing facility. The form’s six inspection observations were:

failure to write and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failure to have statistical quality control criteria to include appropriate rejection levels;
employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions;
aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions;
failure of laboratory records to include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness; and
the quality control unit lacks the responsibility to approve all procedures or specifications affecting the identity, strength, quality, and purity of drug products.

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