HHS Inspector General to Analyze Postmarket Surveillance
HHS’ Office of Inspector General (OIG) announced plans to release a report on the medical device postmarket surveillance system next year. Source: The GMP Letter
FDA Warns Wheelchair Manufacturer for Misbranding
The FDA issued a warning letter to 21st Century Scientific for misbranding of its powered wheelchairs. Source: The GMP Letter
FDA Issues Labeling Advice for Intravascular Devices
In a newly released guidance, the FDA spells out what manufacturers need to consider when labeling catheters, wires and delivery systems with lubricious coatings used during minimally invasive diagnostic and…
FDA Calls for Boxed Warning on Breast Implants
The FDA released new labeling recommendations and called for a boxed warning for breast implants in a new draft guidance. Source: The GMP Letter
FDA Investigates Implantable Devices That Contain Metals
The FDA called for feedback on a newly released report on biological responses to metal implants and said it’s investigating possible adverse events linked to the devices. Source: The GMP…
Iowa Drugmaker Cited for Quality Violations
Iowa drug manufacturer Continental Manufacturing Chemist drew a Form 483 from the FDA for quality failures at its Madrid facility. Source: Drug Industry Daily
GlaxoSmithKline Loses Bid to End Zofran Lawsuits
GlaxoSmithKline lost its bid to end multiple lawsuits against the company alleging that its anti-nausea drug Zofran (ondansetron) caused birth defects. Source: Drug Industry Daily
FDA Suggests Alternative NDMA Test for Ranitidine
The FDA is recommending a second low-temperature test for determining if ranitidine products contain the probable carcinogen N-nitrosodimethylamine (NDMA). Source: Drug Industry Daily
FDA Task Force Supports Rating System for Drug Shortages, Woodcock Says
CDER Director Janet Woodcock said an agency task force supports a new rating system designed to inform purchasers about drug facilities with higher reliability. Source: Drug Industry Daily
FDA Changes Approach to Homeopathic Products, Sharpless Says
In a joint statement, acting FDA Commissioner Ned Sharpless and CDER Director Janet Woodcock announced that the agency is changing its approach to regulating homeopathic drug products that pose significant…
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