We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The saga of troubled generic drugmaker Able Laboratories took yet another turn this month when the company said it intends to sell its assets — a move sparked by the FDA’s rejection of a consent
decree proposal that would have allowed the firm to relaunch its withdrawn drug products without having to resubmit abbreviated new drug applications (ANDAs).
Pharmaceutical firms that implement effective quality risk management systems could see fewer government regulators peering over their shoulders, suggests a new guidance on risk management released by the FDA.
Pharmaceutical manufacturers that implement effective quality risk management systems could see fewer government regulators peering over their shoulders, suggests a new guidance on risk management released by the FDA.
Drug manufacturers that implement effective quality risk management systems could see fewer government regulators peering over their shoulders, suggests a new guidance on risk management released by the FDA.
The FDA has initiated its long-anticipated inspection of Chiron’s Liverpool, England, operation, where the company manufactures its Fluvirin influenza vaccine.
A federal district court judge has issued a permanent injunction shutting down the operations of a Florida drugmaker accused of routinely violating FDA current good manufacturing practices (cGMPs).
Embattled generic drugmaker Able Laboratories, which in May voluntarily recalled its entire product line because of quality problems, is hoping to restart its operations under a consent decree agreement it has proposed to the FDA.
A federal district court judge issued a permanent injunction July 25 shutting down the operations of Pharmakon Laboratories, which is accused of routinely violating FDA current good manufacturing practices (cGMP).
Building a strong quality system based on sound scientific techniques is essential to meeting the FDA's latest cGMP requirements, says an agency official.
A former drug company CEO has been slapped with a permanent injunction after a federal court determined he was aware of cGMP
violations at his company yet failed to take measures to correct the infractions.