Drugs

FDA Releases 2 FDA-483s for Zhejiang Hisun

FDA has just released the FDA-483s issued following 1/16-1/19/2017 and 8/7-8/11/2017 inspections at Zhejiang Hisun Pharmaceutical Co., a Taizhou City, Zhejiang, China, active pharmaceutical ingredient manufacturer. The form for the January inspection had these observations:

failing to follow quality control laboratory control procedures; and
failing to justify labeled storage conditions by stability studies.

The observations from the August inspection were:

laboratory records do not always include relevant metadata to ensure that established procedures are followed;
written procedures are deficient regarding the cleaning and maintenance of equipment;
storage conditions for samples retained for testing are not monitored appropriately;
records are not completed contemporaneously;
laboratory records do not include complete data derived from microbial limit testing to ensure established procedures are followed;
changes to manufacturing processes are not fully documented;
process validating studies do not contain a history of all relevant data; and
the final API storage areas are not maintained in a good state of repair.

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