Drugs

CGMP Deviations at Shree Jaya Unit

A 9/4-9/12/2024 FDA inspection at the Shree Jaya Laboratories drug manufacturing facility in Yadadri Bhuvanagiri District, Telangana, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients. A 2/28 Warning Letter says the specific deviations were:

failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the intermediates beyond the official or other established specifications;
failure of the firm’s quality unit to ensure that quality-related complaints are investigated and resolved; and
failure of the firm’s quality unit to exercise its responsibility to ensure the intermediates manufactured at the facility comply with CGMP.

FDA says the firm’s responses to the inspection observations were inadequate. Shree was told to promptly correct the deviations and to respond with a list of specific actions 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

Read more

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