ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

International – ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials...

To properly inform decision making by pharmaceutical companies, regulators, patients, physicians and other stakeholders, clear descriptions of the benefits and risks of a treatment...
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...
Checklist for sponsors applying for the transfer of Orphan Medicinal Product (OMP) designation

International – Two additional countries to benefit from EU-US mutual recognition agreement for inspections

In February 2019, the US Food and Drug Administration (FDA) confirmed the capability of two additional European Union Member States to carry out good manufacturing practice (GMP) inspections at...
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...

Russia – La Russie annonce avoir développé un médicament contre le Coronavirus

Alors que l’épidémie du coronavirus se propage dans le monde, la Russie a annoncé hier lundi avoir développé un traitement contre le Covid-19 qui...
WHO drafts guidance for pharma supply chain tracking

International – WHO takes stock of global COVID-19 R&D progress

Researchers, developers and funders from across the globe attended the two half-day virtual summit on 1 and 2 July to examine the progress made...
Scientists Have Engineered a Potential New Class of Antibiotic That Can Kill Superbugs

International – Scientists Have Engineered a Potential New Class of Antibiotic That Can Kill...

Right now, it's known simply as G0775. But this simple code could represent a whole new battery of drugs that just might buy us...
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 guidance for pharma supply chain tracking

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...
Differences and similarities between FDA 21 CFR Part 820 and ISO 13485

International – Differences and similarities between FDA 21 CFR Part 820 and ISO 13485

ISO 13485:2016 is a voluntary standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the...

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