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 – 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...
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...
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...
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...
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...
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...
