Search


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...
Sharan Murugan
May 8, 20211 min read
4 views
0 comments


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...
Sharan Murugan
May 8, 20211 min read
10 views
0 comments


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...
Sharan Murugan
May 8, 20211 min read
74 views
0 comments


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...
Sharan Murugan
May 4, 20211 min read
21 views
0 comments


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...
Sharan Murugan
May 4, 20211 min read
9 views
0 comments