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The Safe Medical Devices Act of 1990 (SMDA) is a federal law that requires manufacturers and user facilities and to report any adverse events associated with a medical device to the FDA. In 1997, the SMDA has renamed...
ANVISA, Brazil’s drug regulatory body, announced Wednesday at the RAPS’ Regulatory Convergence that more than 800 new and generic drug application backlogs would be eliminated by January 2019. This elimination would...