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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
Manufacturers of influenza vaccines may obtain marketing authorization in the EU based on less-than-comprehensive applications if they supplement their filings with clinical trial data after a pandemic is declared, the European Medicines Agency says. Read More
A panel of judges from the Federal Circuit Court of Appeals has ruled that two of The Medicines Company’s patents for its anticlotting drug Angiomax are invalid — a win for Hospira, which is planning a generic version of the treatment. Read More
The U.S. government and 11 states are seeking as much as $3.3 billion from Novartis over an alleged kickback scheme involving its Exjade and Myfortic drugs, according to documents filed in the U.S. District Court for the Southern District of New York. Read More