Drugs

Akorn Pharmaceuticals Inspection Observations

A just-released FDA-483 details observations from a 6/1-6/10 inspection of Akorn Pharmaceuticals, Decatur, IL. Specific observations included:

failing to record and justify deviations from written production and process control procedures;
failing to fully follow responsibilities and procedures applicable to the quality control unit;
failing to extend investigations of a failure of a batch or any of its components to meet any of its specifications to other drug products that may have been associated with the specific failure or discrepancy;
failing to have quality controls include a determination of conformance to written descriptions of sampling procedures for drug products;
failing to have laboratory controls include establishment of scientifically sound and appropriate sampling plans designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality, and purity;
failing to verify under actual conditions of use the suitability of all testing methods; and
failing to establish control procedures that validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

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