WHO Seeks to Expand Access to Insulin With Prequalification Program

International – WHO Seeks to Expand Access to Insulin With Prequalification Program

As only about half of the 65 million people worldwide with Type 2 diabetes who need insulin can access it, the World Health Organization...
ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry

International – ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry

A recently released survey from the International Council on Harmonisation (ICH) shows pharmaceutical regulators and companies around the world are adopting and adhering to...
ICH Survey Shows Wide Adoption of Guidelines Among Regulators, Industry

International – ICH Updates: What to Expect Through 2020

At a joint public consultation in Ottawa on Monday, officials from Health Canada and the US Food and Drug Administration (FDA) gave an overview...
Evolving Global Regulatory Landscape, Strategies and Best Practices

International – Evolving Global Regulatory Landscape, Strategies and Best Practices

October feature articles reported on a number of timely issues facing regulatory professionals today, including the advantages of using periodic safety update reports, practical...
PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

International – PIC/S Opens Consultations on Manufacturing ATMPs, Biological Medicinal Substances

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is seeking comments on revisions to two parts of its GMP Guide (Annex 2A and Annex 2B) that...
FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

International – FDA Collaborates With Health Canada, Australia to Approve New Cancer Drugs

The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework...
Médicaments : quelle(s) réalité(s) ?

International – Médicaments : quelle(s) réalité(s) ?

Le blog Rédaction Médicale et Scientifique a publié pas moins de 17 billets durant le mois d'août 2019 avec des données réalistes sur les...
Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas

International – Two New FDA, HHS Plans to Allow Drug Importation From Canada, Overseas

As part of plans to lower the cost of prescription drugs, the US Department of Health and Human Services (HHS) and the Food and...
WHO Seeks to Expand Access to Insulin With Prequalification Program

International – WHO Revises Guidance on QMS Requirements for National Inspectorates

The World Health Organization (WHO) has revised its guidance on quality system requirements for national good manufacturing practice (GMP) inspectorates to align with international...
Top 9 Companies in the Diagnostics Market

International – Top 9 Companies in the Diagnostics Market

Add some market clearances; a rebranding; a merger or two; and some collaborations; and you’ve got a recipe for some of the most powerful...

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