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...

International – European Commission, EMA and FDA agree new priorities to strengthen their collaboration...

Senior officials from the European Commission (EC - DG SANTE), EMA and the United States Food and Drug Administration (FDA) held their 2020 bilateral...
Generic Drugmakers Oppose 10 Years Exclusivity for Biologics in US-Mexico Deal

International – Generic Drugmakers Oppose 10 Years Exclusivity for Biologics in US-Mexico Deal

As part of a preliminary trade deal between the US and Mexico, to update the 24-year-old North American Free Trade Agreement (NAFTA), both sides agreed...
ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH Offers Updates on Guidelines, Working Groups

In addition to updates on how ICH regulatory members are implementing ICH guidelines, the ICH Assembly at its meeting in Charlotte, NC, on 14-15...

International – Covid : l’OMS appelle à augmenter la production mondiale de dexaméthasone

« Le prochain défi consiste à augmenter la production et à distribuer rapidement et équitablement la dexaméthasone dans le monde entier, en se concentrant...

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