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Andrx did not properly investigate product discrepancies and out-of-specification results, according to observations listed on the Form 483 the FDA issued to the company after the agency’s reinspection of the drugmaker’s plant in March.
Andrx’s CEO will get a $700,000 bonus for 2005 despite manufacturing problems that have stalled all the company’s pending drug applications, according to documents filed with the Securities and Exchange Commission (SEC).
Pharma companies should not view adherence to the FDA's encouragement of IT adoption as a costly unfunded mandate, but rather as an opportunity to grow the business, according to experts at a recent industry conference.
In an effort to protect patients from counterfeit products, GlaxoSmithKline (GSK) has attached radio frequency identification (RFID) tags to all bottles of its HIV treatment Trizivir distributed in the U.S.
Industry officials are hesitant to adopt the FDA’s planned changes to its good manufacturing practices (GMP) policy until the agency finalizes its new manufacturing requirements, sources say.
Top pharmaceutical executives must play a more active role in overseeing GMP initiatives under the FDA’s new approach to risk management, according to an industry expert who also urged firms to start applying quality manufacturing concepts earlier in the drug development process.