Category: India
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STAT+: An API supplier in India wants you to know its metal detector is working just fine
STAT+: An API supplier in India wants you to know its metal detector is working just fine For those wondering about any metallic particles found in active pharmaceutical ingredients made by a supplier called Hikal, you can rest easy — the company says its metal detector is working again. Since 2020, nearly two dozen complaints…
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STAT+: FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues
STAT+: FDA tells drugmakers to redo studies run by a contract research firm due to data integrity issues In a rare move, the Food and Drug Administration told an unspecified number of drug companies that studies used to support therapeutic equivalence of some of their medicines have been rejected due to false data generated by…