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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
Washington State Gov. Jay Inslee has signed legislation allowing pharmacists to substitute biosimilars for brandname biologics, joining a growing list of states that have passed such laws. Read More