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After more than three-and-a-half years of compliance efforts, Schering-Plough has completed an extensive current good manufacturing practice (cGMP) overhaul required under a consent decree reached with the FDA in 2002.
The FDA plans to re-inspect Andrx’s manufacturing facility to resolve good manufacturing practice (GMP) concerns, but did not indicate when it would conduct the inspection, Andrx said in a recent SEC filing.
Andrx plans to meet with the FDA on Dec. 14 to discuss manufacturing issues that have stalled the company's drug approvals, Andrx said in a recent filing with the Securities and Exchange Commission (SEC).
OTC drugmaker Molecular Biologics (MBI) has signed a consent decree with the FDA requiring it to cease manufacturing and distributing its drug products until it can resolve repeated manufacturing violations at its Benicia, Calif., plant.
Andrx will meet with the FDA on Dec. 14 to discuss manufacturing issues that have stalled the company’s drug approvals, Andrx said in a recent filing with the Securities and Exchange Commission (SEC).
OTC drugmaker Molecular Biologics (MBI) has signed a consent decree with the FDA requiring it to cease manufacturing and distributing its drug products until it can resolve repeated manufacturing violations at its Benicia, Calif., plant.
Andrx plans to meet with the FDA around Thanksgiving to discuss manufacturing violations that have stalled approval of its drug applications. The company, which requested the meeting, said the FDA has not yet commented on any of its responses to the inspectional observations.
Chiron will soon begin shipping flu vaccine to U.S. distributors for the first time since its operations were shuttered roughly one year ago because of manufacturing deficiencies.