Drugs

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

StemGenex Biologic Laboratories San Diego, CA (10/31): FDA inspected the firm in January and cited it for illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations. FDA says the firm’s stromal vascular fraction is administered in a variety of ways for treating diseases and conditions, including, Alzheimer’s disease, Crohn’s disease, Type I and Type II diabetes, fibromyalgia, spinal cord injury, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson’s disease, peripheral neuropathy, and rheumatoid arthritis. Additionally, FDA investigators cited the firm over its unvalidated manufacturing processes, uncontrolled environment, lack of control of components used in production, and lack of sufficient and validated product testing (sterility and endotoxin testing).
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm625497.htm

U.S. Vascular, Beaverton, OR (6/7): FDA inspected the firm in March and cited GMP deficiencies with manufactured medical devices. For example, the firm’s procedures for design control have not been established. Additionally, procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm625034.htm

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