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…
FDA Clarifies Its Approach to Postmarket Studies and Clinical Trials
In a draft revision of an April 2011 guidance, the FDA has laid out its current thinking on when the agency may require postmarket studies or clinical trials for approved…
Reckitt Settles Multistate Suboxone Claims for $700 Million
Reckitt Benckiser (RB Group) has agreed to pay $700 million to settle multiple lawsuits filed by states in federal courts over marketing practices for its addiction treatment drug Suboxone (buprenorphine).…
IMDRF Flags Lack of ‘Global Alignment’ in Cybersecurity
Devicemakers should assess cybersecurity risks throughout the product lifecycle, the International Medical Device Regulators Forum (IMDRF) says, in a new draft guidance that calls for “convergence of global healthcare cybersecurity…
483 Roundup: FDA Hits Six Firms for Quality Management Lapses
The FDA cited six devicemakers for a variety of quality problems uncovered during the agency’s inspections of their facilities. Source: The GMP Letter
FDA Creates New Safer Technologies Program
The FDA is introducing a new review program for certain medical devices and device-led combination products that are expected to significantly improve the safety of treatments for a disease or…