Drugs

Morton Grove Closes Business Over GMP Violations

The Northern District of Illinois federal court has approved a consent decree of permanent injunction that orders Morton Grove Pharmaceuticals to stop making and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). Under the decree, the firm decided for commercial reasons to close its business and sell the site. Further, it must destroy all drugs at the facility except those identified as medically necessary.

Morton Grove was making prescription and over-the-counter drugs, such as cough syrups and nasal sprays at the time of the decree. The government contends that the company violated the FDCA by “failing to have adequate procedures to prevent cross-contamination of equipment, failing to reject drug lots using a contaminated ingredient, and failing to fully investigate the root cause of such contamination,” according to a Justice Department release. It cites inspections in 2011, 2014, 2016, 2019 and 2021, noting that many violations were repeat findings identified in earlier inspections.

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