Drugs

FDA Taking Steps to Ease Saline Shortage: Gottlieb

FDA commissioner Scott Gottlieb says FDA is working closely with companies that manufacture saline to limit and improve the shortage issues, using all of its tools and resources. In an update, Gottlieb says the agency expects supplies of saline to increase over the next month. He notes that having adequate supplies, especially during this severe flu season, is a critical matter of public health.

Recently, the statement says, FDA was able to extend the expiration dates of certain products, including some 550 ml size saline bags, after carefully examining the data submitted by the company to ensure that it meets the agency’s quality and safety standards. “We continue to encourage companies to submit data to extend expiration dates for drugs in shortage,” Gottlieb writes. “We’ve also been working with manufacturers such as Baxter and B. Braun to import products into the U.S. from their foreign facilities, including most recently additional products from a Baxter facility in Brazil.”

FDA also has been proactively engaging with providers, manufacturers, distributors, and other partners to identify and address issues affected by other products, such as empty IV containers that are being used by many healthcare providers to compound their own saline solutions by filling the containers, Gottlieb says. “By engaging with these partners,” he says, “we can better identify the types of empty IV containers and other medical products, we can better identify the types of empty IV containers and other medical products that are most in demand. We’re also working to identify the specific features of products that are preferred or required by healthcare providers, such as size or function of the containers. We’re using this aggregated information, and sharing it with existing and new manufacturers, to help identify existing supply gaps. We’re taking steps to fill these gaps. Several manufacturers have indicated to us that they have the potential to initiate or ramp up production of empty IV containers to help address these public health risks.”

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