Drugs

Company Ordered to Stop Selling OTC Drug Products

A Tennessee federal judge has entered a consent decree sought by FDA against Keystone Laboratories, Memphis, TN, and its owner and president, barring them from selling over-the-counter drug products until the firm complies with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the decree. A complaint filed with the decree says Keystone manufactured and distributed OTC hair care and skin care products that violated federal law.

The complaint says that Keystone’s products were not manufactured, processed, packed, or held according to CGMP requirements. It also says that some of the drugs were misbranded because the product labels did not include adequate directions for use or other label requirements for OTC drug products.

The consent decree requires Keystone to cease operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure that the company complies with the law and its implementing regulations. Under terms of the decree, Keystone may not resume operations until it establishes and implements a comprehensive quality control system and receives authorization from FDA, among other requirements.

FDA issued a Warning Letter to Keystone in 3/2013 for similar violations as cited in the complaint. The agency inspected the facility in 2/2016 and 11/2017 and observed repeat violations.

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