Drugs

CGMP Deviations at Hangzhou Yiqi Biotechnology

An FDA review of records it requested from Hangzhou Yiqi Biotechnology Co., an active pharmaceutical ingredient manufacturer in Hangzhou, Zhejiang, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 4/15 Warning Letter says the specific deviations were:

failure to demonstrate that the firm’s manufacturing process can reproducibly manufacture an API meeting the predetermined quality attributes;
failure to validate and verify the suitability of analytical methods;
failure to design a documented, ongoing sterility testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates; and
failure to demonstrate that water used in the manufacture of APIs is suitable for its intended use.

FDA placed all of the company’s drugs and drug products offered for import into the U.S. on a 1/30 Import Alert. Hangzhou was told to correct the deviations promptly and to respond with a list of specific steps it has taken to address the deviations and prevent their recurrence, with a schedule for completing the corrections.

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