Biologics

Consider Mfg. Issues in Preparedness Planning: GAO

The Government Accountability Office (GAO) says that as HHS develops a new program to improve domestic infrastructure and expertise to produce medical countermeasures such as drugs and vaccines in response to public health emergencies, it should incorporate an approach to systematically assess and respond to known challenges and risks associated with the advanced development of medical countermeasures. The recommendation is in a GAO report on the former HHS Centers for Innovation in Advanced Development and Manufacturing (CIADM) program that had three sites responsible for, among other things, rapidly producing countermeasures for a pandemic.

The report says HHS found, often through FDA inspections, that the sites faced challenges in reliably producing products on a large scale, such as poor quality control, that eventually led to the closing of one site (Emergent) due to cross-contamination.

GAO says that as HHS transitions from its former CIADM program to a new National Biopharmaceutical Manufacturing Partnership, “incorporating an approach to address these challenges and risks would provide HHS with greater assurance that it can avoid the challenges of the CIADM program.”

HHS concurred with the recommendation, GAO says.

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