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New FDA-approved labeling for the antibiotic meropenem adds another pediatric indication to the drug’s portfolio, this time for treating complicated intra-abdominal infections in children younger than three months old. Read More
The U.S. Supreme Court has declined to review a lower court ruling that upheld a California county ordinance requiring drugmakers to collect and dispose of unwanted drugs, in an outcome that could end up costing industry millions of dollars. Read More
Sponsors looking to determine whether their drugs have impurities that might lead to cancer-causing mutations in human DNA should conduct two toxicology assessments using mathematical models that base this probability on the drug’s chemical structure. Read More
Canada lags significantly behind other developed countries in providing coverage for new medicines, with Canadians waiting on average 462 days for novel, potentially lifesaving drugs, a new report shows. Read More
The Saudi Food and Drug Authority is seeking feedback on a proposed list of definitions for terms associated with good pharmacovigilance practices. Read More
The FDA has updated its guidance on refuse-to-receive criteria for ANDAs to include a reference to the Office of Pharmaceutical Quality, which didn’t exist when the guidance was finalized. Read More
Germany’s healthcare cost watchdog has recommended against paying for Celgene’s Otezla, citing a lack of evidence that the psoriasis drug offers added benefit over available therapies. Read More