Drugs

New FDA Steps to Improve Drug Compounding

FDA has released its 2019 priorities to improve the quality of drug compounding. In a statement from FDA commissioner Scott Gottlieb and deputy commissioner Anna Abram, the agency says it will use funds in the 2019 budget to lay the groundwork for a Center of Excellence on Compounding for Outsourcing Facilities, including providing training programs on current good manufacturing practice requirements for outsourcing facilities.

The agency also plans to continue efforts to help compounders to identify insanitary conditions in compounding facilities so they can implement appropriate corrective actions.

The statement reviews other steps that have already been taken and will be coming throughout this year. Gottlieb and Abrams say a May public meeting will discuss current good manufacturing practice (CGMP) for outsourcing facilities and gain public feedback to gauge the potential impact of proposed policies related to CGMP requirements on office stock access for healthcare providers. And FDA will hold additional listening sessions with stakeholders to better understand their views on key issues such as the substances included on the bulks list and manufacturing requirements for outsourcing facilities as policies are developed that ensure appropriate access while protecting public health.

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