Drugs

FDA Releases Biocon Inspection 483

FDA has released the FDA-483 issued following a 3/27-4/7 agency inspection at Biocon Limited, Bangalore, India. Specific violations were:

discrepancies between information submitted in an undisclosed document and the manufacturing process at the facility;
the company quality assurance unit has approved and implemented documents that do not assure appropriate production, testing, and deviation review and release of commercial material;
inadequate handling of in-process samples;
lack of quality oversight in the review of procedures followed in the quality control testing of an unidentified drug substance and drug product;
The out-of-specification (OOS) procedure for non-conforming materials and drug products does not ensure satisfactory conformance to batch release specifications and appropriate investigation and tracking of OOS events because it is internally inconsistent and not clear;
unidentified solutions for drug substance formulation do not have adequate microbial control;
bioburden sampling during manufacturing of an unidentified drug product is inadequate; and
deviations are not initiated and/or closed in time per the deviation standard operating procedure and do not include appropriate justifications for closure delays.

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