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Aug. 19, 2019

Vol. 18
No. 159


FDA and EMA on the Same Page for Most Drug Approval Decisions, Analysis Shows

A study by the FDA and EMA comparing their decisions on drug marketing applications found the two agencies align in most cases — but sometimes reach different conclusions about a drug’s efficacy. Read More

Court Rules That Price-Fixing Lawsuit Against Drugmakers Can Continue

A federal court in Pennsylvania has ruled that price-fixing litigation against several dozen generic drugmakers can go ahead. Read More

Spectrum Laboratory Warned Again for GMP Failures

Just months after being rapped for violations at its Gardena, California facility, Spectrum Laboratory received another warning letter from the FDA, this time for similar GMP violations at its New Jersey API manufacturing plant. Read More

South Korean OTC Drugmaker Cited for Cleaning, Data Issues

The FDA found “moldlike” growth and other contaminants at Kumho Dental Pharmaceutical’s over-the-counter dental drug facility in Seoul, South Korea. Read More