Drugs

Global Calcium FDA-483 Has 6 Observations

FDA has released the form FDA-483, with six observations from a 1/27-2/3 inspection at Global Calcium Pvt. Ltd., an active pharmaceutical ingredient manufacturer in Hosur, India. The specific inspection observations were:

failure of laboratory records to include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards;
failure to follow established sampling plans and test procedures;
failure of laboratory controls to include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to established specifications;
cleaning procedures are not appropriate or reproducible to prevent contamination that would alter the safety, identity, strength, quality, or purity of the finished drug substances;
failure to establish and maintain an effective Quality System to prevent Data Integrity breaches and to ensure employees can report GMP-related concerns without fear of identification or retaliation; and
failure to fully follow the responsibilities of the Quality Unit.

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