FDA Policy/General

Animal Drug API GMP Guidance

FDA has published a Veterinary International Conference on Harmonization guidance, Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products, to give guidance regarding good manufacturing practice for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. The document says it also is intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess.

The guidance includes an Introduction; Quality Management; Personnel; Buildings and Facilities; Process Equipment; Documentation and Records; Materials Management; Production and In-Process Controls; Packaging and Identification Labeling of APIs and Intermediates; Storage and Distribution; Laboratory Controls; Validation; Change Control; Rejection and Re-use of Materials; Complaints and Recalls; Contract Manufacturers (Including Laboratories); Agents, Brokers, Traders, Distributors, Repackers, and Relabelers; Specific Guidance for APIs Manufactured by Cell Culture/Fermentation; APIs for Use in Clinical Trials; Glossary; and References.

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