Drugs

Data Integrity is Biggest Inspection Issue: FDA

CDER Office of Manufacturing Quality compliance officer Yasamain Ameri says data integrity is the biggest issue that is identified by FDA investigators conducting inspections around the world. As reported in the Regulatory Affairs Professionals Society Regulatory Focus online newsletter, Ameri spoke recently at the Orange County (CA) Regulatory Affairs Discussion Group annual conference.

She said FDA had issued 60 current good manufacturing practice Warning Letters as of 5/24, with 21 going to U.S. companies, seven in China, seven in India, two in Mexico, and 21 in other areas of the world. Most of the letters related to routine surveillance (40%), first surveillance (35%), section 704(a)(4) (authorizing FDA to conduct inspections at reasonable times, within reasonable limits, and in a reasonable manner). (20%), and sample collection and testing (5%), Ameri reported. She said the Center is on track to issue a similar number of Warning Letters as in 2023, and the proportions of evidence types cited in the letters are also similar to the previous year.

Nearly all the 2024 Warning Letters involved over-the-counter drugs (88.3%), followed by active pharmaceutical ingredients (8.3%) and finished prescription drugs (3.3%).

Ameri reported that firms are commonly cited for issues related to aseptic manufacturing, microbial contamination, cleaning and cross-contamination, poor excipient quality and manufacturing controls, facility design and maintenance, and supply chain globalization and contract manufacturing.

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