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Expectations & Challenges in Conducting Virtual Inspections- USFDA and EMA

Regulators from 11 agencies, representing the US, the UK, Spain, Germany, and Russia, discussed their views on these challenges and...

Guideline for Medical Devices Bundling for MAA- Ethiopian Food and Drug Authority (EFDA)

This guideline is intended to provide general criteria for bundling medical devices within one medical device marketing authorization...

Guidance documents for Therapeutic Products (e-labelling) – SINGAPORE

The Therapeutic Products Branch (TPB) finalized guidance on e-labelling of therapeutic products (TPs) in Singapore has been published and...

Finalized Guidance on Parallel MAA, EU-M4all procedure -EMA

The European Medicines Agency (EMA) on 22 April 2021 released the final version of its guidance for parallel EU-M4all (Article 58) and...

FDA Offers guidance on Generic Drug Development- COVID

US Food and Drug Administration (FDA) On April-5, 2021 released new questions and answers guidance for generic drug makers briefing...