Drugs

FDA Seeks Comments on AI Areas in Drug Manufacturing

FDA is seeking comments on a just-released discussion paper on artificial intelligence (AI) areas for use in drug manufacturing and policy development associated with such use. The paper is based on issues raised in a 2021 National Academies of Sciences, Engineering, and Medicine report titled “Innovation in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations,” which highlights innovations in integrated pharmaceutical manufacturing processes.

The innovations discussed in the report “could have implications for measurement, modeling, and control technologies used in pharmaceutical manufacturing,” an FDA notice says. “AI may play a significant role in monitoring and controlling advanced manufacturing processes.”

The paper says CDER scientific and policy experts identified the discussion areas from a “comprehensive analysis of existing regulatory requirements applicable to the approval of drugs manufactured using AI technologies… There are additional areas of consideration not covered within this document, for example, difficulties that could result from ambiguity on how to apply existing regulations to AI or lack of agency guidance or experience.”

FDA says that while its initial AI analysis focused on products regulated by CDER, CBER is also seeing a rapid emergence of advanced manufacturing technologies associated with AI, and so CBER stakeholders are invited to submit comments too.

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

Read more

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