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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
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
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
Six years after promising a web-based alternative to its electronic submissions gateway, the FDA has launched a drug safety reporting portal for companies with a small number of adverse event reports. Read More