Drugs

Lessons from FDA Aseptic Mfg. Inspections

CDER senior policy advisor Brooke Higgins says FDA has seen inspection trends in aseptic technique and behaviors; facility, room, and process design; and the use of media fills. An online report in Healthcare Packaging covers Higgins’ presentation at the 9/2021 Parenteral Drug Association/FDA joint regulatory conference.

“We know it takes a myriad of meticulous steps to ensure the quality of sterile drug products,” Higgins told the conference. “This includes fastidious control over the sterile drug, container closures, and components, and careful and attentive interactions in the processing and surrounding area.”

In control strategy, she said, FDA requires manufacturers to run all processes by the agency to ensure proper protection from microbiological contamination of drug products purporting to be sterile. It also insists a current good manufacturing practice-compliant firm must continually assess its systems and take action on time to ensure that it remains in a state of control, including the facility, the equipment, and the process. FDA expects companies to assess the effectiveness of controls and measures in place to minimize the risk of contamination, she said.

Areas of contamination concern Higgins discussed were personnel; facility, room, and process design; smoke studies; and media fills.

She also highlighted technologies that she said can better protect the product from contamination during aseptic processing.

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