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May 8, 20211 min read

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...

May 8, 20211 min read

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...

May 8, 20211 min read

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...

May 4, 20211 min read

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...

May 4, 20211 min read

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...