Drugs

OIG Sees Medical Device, Drug Risks

HHS deputy inspector general for evaluation and inspections Suzanne Murrin says the Office of Inspector General has identified risks associated with medical device safety and security and safety concerns with FDA-regulated drugs. In testimony before the House Appropriations Committee, Murrin says FDA:

needs to further mitigate the risk of cybersecurity threats to medical devices;
needs to ensure a robust postmarket surveillance system for medical devices;
should further address concerns about the of foreign drug manufacturing;
should further look into how drug supply chain security is compromised by incomplete drug tracing records; and
should ensure that non-patient-specific compounded drugs are obtained from compounders that meet FDA quality standards.

The testimony also included food safety recommendations.

Murrin told the committee that OIG is expanding its oversight to include the agency’s role in combating the opioid crisis, FDA actions to foster drug competition, and FDA involvement in curtailing youth tobacco use.

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