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USFDA Guidance: Application User Fees for Combination Products

The US Food and Drug Administration published the revised final guidance Application User Fees for Combination Products yesterday (16...

EMA Med Dev. Guidance: New Guidance for Industry and Notified Bodies

The European Medicines Agency (EMA) has recently released updated Q&A guidelines "New Guidance for Industry and Notified Bodies" that...

Australia TGA: Regulation of Software based Medical Devices

On 9th May 2023 Australia's Therapeutic Goods Administration (TGA) released an updated "Regulation of Software-based Medical Devices"...

South Africa's (SAPHRA) Guideline for Fixed-Dose Combination Products

Earlier today (07-February-2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline for...

USFDA Guidance on Premarket Review of Combination Products

US Food and Drug Administration (FDA) has finalized guidance for industry and agency staff on the use of Principles of Premarket Pathways...