Drugs

ADMA Biologics FDA-483 Has 8 Observations

FDA has released the FDA-483 issued following a 4/3-4/12 inspection at ADMA Biologics, Boca Raton, FL. The document’s eight observations were:

failing to prevent unauthorized access of changes to data and to provide adequate controls to prevent omissions of data;
failing to control issuance and use of documents;
failing to thoroughly investigate discrepancies;
failing to have written quality unit responsibilities;
failing to have studies demonstrating that equipment does not alter drug substance quality;
failing to establish and follow scientifically sound test procedures;
failing to adequately establish or follow procedures for monitoring and maintenance of facilities and equipment; and
failing to have procedures describing sanitizers and sanitizing schedules that have been shown to be effective.

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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