Drugs

FDA Finds 11 Problems at Bayer Facility

The just-released FDA-483 issued following a 1/13-1/20/17 inspection at the Bayer Pharma facility in Leverkusen, Germany, that produces parenteral, solid oral dosage, and active pharmaceutical ingredient drugs contains 11 inspection observations. Specific violations were:

failing to ensure appropriate environmental conditions for filling parenteral products;
failing to establish procedures to ensure reliable detection of particulate matter in parenteral products;
failing to establish and follow procedures for cleaning of equipment and the facility;
failing to establish a document control system;
failing to conduct thorough complaint investigations and extend the investigation to related batches;
failing to establish separate areas to prevent cross-contamination;
failing to perform a thorough investigation into a discrepancy;
failing to have facilities and equipment of a suitable design for their intended use;
failing to maintain and review all analytical data;
failing to establish test procedures for analytical testing; and
· failing to record data contemporaneously.

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