Drugs

FDA Releases Bio-Thera Solutions FDA-483

FDA has released the form FDA-483 issued following a 1/7-1/17/2025 inspection at the Bio-Thera Solutions drug substance and drug product manufacturing facility in Guangzhou, Guangdong Province, China. The six inspection observations were:

failure to fully establish or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
there is a lack of assurance that the company’s manufacturing operations in the drug substance production area are appropriately designed to ensure the prevention of contamination of equipment or products by environmental and processing conditions that would be expected to have an adverse effect on product quality;
failure to fully establish or follow written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
failure to establish adequate procedural controls to protect the electronic data acquisition and process control systems used for manufacturing of redacted items in the manufacturing facility;
responsibilities and procedures applicable to the quality unit are inadequate; and
failure of laboratory controls to include the establishment of scientifically sound and appropriate standards designed to assure that components and in-process materials conform to appropriate standards of identity, strength, quality, and purity.

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