Drugs

FDA Highlights GMP Warning to Chinese OTC Drug Maker

FDA is pointing to a new Warning Letter to a Chinese drug manufacturer as evidence of its increased “oversight of over-the-counter drug manufacturing and protecting consumers from products that may put them at risk.” The Warning Letter to Ningbo Huize Commodity cited GMP violations, including data integrity issues, associated with its sunscreens.

The letter details a “failure to have adequate quality control mechanisms in place,” according to an FDA release. “The company provided FDA investigators multiple documents that were falsified, including the cleaning validation reports and batch production and control records for multiple drugs. The firm also provided records showing they performed the required periodic reviews of their operation to assure quality, which they later admitted were also falsified. These CGMP violations cause all drugs manufactured by Ningbo Huize to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).”

FDA’s release notes that a 2018 guidance for industry updates its recommendation on ensuring data integrity and compliance with GMPs. “Pharmaceutical quality can only be assured by robust quality control, which includes vigilant oversight of data integrity,” it says.

Following the inspection in March, FDA says it placed the company on import alert in June to prevent their drugs from entering the U.S. The company has also agreed to recall its drugs.

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