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GlaxoSmithKline lost its bid to end multiple lawsuits against the company alleging that its anti-nausea drug Zofran (ondansetron) caused birth defects. Read More
The FDA is recommending a second low-temperature test for determining if ranitidine products contain the probable carcinogen N-nitrosodimethylamine (NDMA). Read More
CDER Director Janet Woodcock said an agency task force supports a new rating system designed to inform purchasers about drug facilities with higher reliability. Read More
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 risks to patients. Read More
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 prescription drugs. Read More
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). Read More