Mylan recalls 15 lots of blood-pressure drug containing valsartan

International – Mylan recalls 15 lots of blood-pressure drug containing valsartan

Mylan (NASDAQ:MYL) starts a voluntary U.S. recall of select lots of Valsartan-containing products due to trace amounts of an impurity that's classified as a probable human...
WHO drafts guidance for pharma supply chain tracking

International – Coronavirus : l’OMS réfute l’utilisation de médicaments sans preuve d’efficacité

« Ces morts et ces contaminations sont des chiffres tragiques, mais n’oublions pas que dans le monde entier, il y a des centaines de...
Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

International – Updated: US-EU Agreement on GMP Inspections Adds 5 More Member States

The US Food and Drug Administration (FDA) earlier this month confirmed the capabilities of Belgium, Denmark, Finland, Estonia and Latvia so that FDA can...
Note on EU implementation of ICH Q12 (guideline on technical and regulatory considerations for pharmaceutical product lifecycle management)

International – ICH E8 General considerations for clinical studies

The ICH guideline 'General considerations for clinical studies' is intended to describe internationally accepted principles and practices in the design and conduct of clinical studies that...
Examining US FDA criteria for medical device cybersecurity and risk management

International – FDA to Follow EMA With Move From London to Amsterdam

As the US Food and Drug Administration (FDA) now communicates with its European counterparts on a daily basis, the US agency has decided to...

International – Medical Writing: The Language and Art of Scientific Communication

Medical writers (MWs) are professionals from diverse backgrounds who address different business needs. Writers hone their skills over the years and master the art...
India Adds Four Medical Device Types to CDSCO List of Regulated Products

India – India’s CDSCO Seeks Feedback From Users of Online Drug, Medical Device Portals

India’s Central Drugs Standard Control Organization (CDSCO) is seeking feedback on its Sugam online portal. The consultation is designed to ascertain how users feel...
WHO Drafts Guideline on Data Integrity for Pharmaceuticals

International – WHO reviewing hydroxychloroquine safety data

The World Health Organization (WHO) on Tuesday promised a swift review of data on hydroxychloroquine, probably by mid-June, after safety concerns prompted the group...
The Q&A is divided into six sections

International – WHO Opens Consultation on New Biosimilar Q&A

As part of plans to clarify earlier biosimilar guidance, the World Health Organization (WHO) has drafted a new document outlining answers to questions regulators...
New Council of Europe resolution to promote pharmaceutical care in Europe

International – L’EDQM et l’ANVISA signent un accord sur la qualité des médicaments

La Direction européenne de la qualité du médicament & soins de santé (EDQM) et l’ANVISA, l’agence brésilienne de surveillance sanitaire, ont annoncé aujourd’hui avoir...

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