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CDER plans to spread drug company inspections across three of its offices — the Office of Regulatory Affairs, Office of Pharmaceutical Quality and Office of Compliance — rather than conduct all inspections through OPQ, center officials said Wednesday. Read More
A recent survey showing that drug company executives are often unaware of problems faced by their quality control units may point to an overlooked contributing factor in FDA warning letters, an expert says. Read More
A Luxembourg-based nonprofit set up by European pharma groups is one step closer to launching a counterfeit drug repository system, having finalized contracts with three software firms to help implement the system. Read More
Mylan expanded its nationwide recall of injectable gemcitabine and methotrexate to the hospital and user level, recalling eight more lots of the drugs after foreign matter was seen during quality control tests. Read More
Dr. Reddy’s Laboratories is recalling drugs used to treat seizures and high blood pressure from the U.S. market due to dissolution and potency issues. All of the affected products were manufactured at DRL’s Bachupally, Hyderabad, India, facility, FDA enforcement reports show. Read More
The FDA and the European Medicines Agency are working to increase regulatory collaboration, including harmonizing their respective pharmacovigilance and quality by design programs, officials from both agencies said June 18. Read More
The Office of Pharmaceutical Quality’s “One Quality Voice” is “well on its way to becoming a reality,” CDER Director Janet Woodcock said June 17. Read More
ISPE’s quality metrics team will collect data from drugmakers in 13 key areas under the second phase of a pilot program to help the FDA boost quality compliance. Read More
If the FDA were to implement a quality metrics program similar to the collection of the 16 metrics used in ISPE’s Quality Metric Pilot Program, the cost would be about $75,000 annually per company, or $35 million across the industry, ISPE says. Read More
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More