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Congress voted Monday afternoon to re-open the government after failing to pass a stopgap measure over the weekend, which shut down federal agencies — but concerns remain about an upcoming standoff and the possibility of another shutdown in February. Read More
The FDA issued drugmaker Milan Laboratories (India) a Form 483 over quality and sanitation problems observed during an August inspection of the firm’s Navi Mumbai facility. Read More
The FDA issued a final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling. Read More
The Seventh Circuit Court of Appeals in Chicago declined to revive several lawsuits against Pfizer over its testosterone drug Depo-T that had previously been among thousands of complaints in multidistrict litigation against testosterone drug manufacturers. Read More
Congress’s failure to pass a government funding bill last weekend means much — but not all — of FDA’s work will stop until an appropriations bill is passed. Read More
Congress’s failure to pass a government funding bill last weekend means much — but not all — of FDA’s work will stop until an appropriations bill is passed. Read More
The FDA warned Chinese drugmaker Yicheng Chemical for inadequate documentation and manufacturing methods that could cause potential cross-contamination. Read More