China CFDA releases 2016 Drug Review Annual Report

China Food and Drug Administration (CFDA) recently released the 2016 Drug Review Annual Report. The Annual Report describes the general situation of drug registration acceptance, review and approval in 2016, and analyzes the data of acceptance and review in 2016 for chemical drugs, traditional Chinese medicines and biological products respectively.

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Medical Device Reporting for Manufacturers, Guidance for Industry and Food and Drug Administration Staff (FDA)

The guidance outlines manufacturer’s responsibilities for reporting adverse events to FDA. Unless exempted, manufacturers must implement written procedures addressing Medical Device Reporting (MDR) requirements. Guidelines for follow-up investigations and addressing event reports in the medical or scientific literature are included.

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Deciding When to Submit a 510(k) for a Software Change to an Existing Device (FDA)

The device guidance updates FDA requirements for determining when a 510(k) premarket notification is required for device changes. It offers principles and flow charts for assessing label changes, and assessing technology, engineering, performance, and materials changes for in vitro diagnostic and non-IVD devices. Also included are risk assessment considerations, case … Continue reading

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