A Right Royal Deadlock: Can "Crown" use unlock patented drug?

UK – A Right Royal Deadlock: Can « Crown » use unlock patented drug?

Following a two year deadlock between the NHS and Vertex Pharmaceuticals, the NHS, in July 2018, offered to make the 'largest ever' financial commitment...
FDA suggests letting more patients with viral infections into cancer clinical trials

USA – FDA suggests letting more patients with viral infections into cancer clinical trials

On the pages of oncology clinical trials on the database ClinicalTrials.gov, the section listing the various criteria that patients must meet for enrollment commonly...
FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

USA – FDA Finalizes Guidance on Nonclinical Drug Development for Serious Hematologic Disorders

The US Food and Drug Administration (FDA) on Thursday finalized guidance on the nonclinical studies drugmakers should conduct when developing products to treat severely...
Health Canada Begins Release of Clinical Data on Drugs and Devices

Canada – Health Canada Begins Release of Clinical Data on Drugs and Devices

Health Canada launched two public databases on Wednesday as the first step in making clinical information about the safety and effectiveness of drugs and...
Risk-Based Monitoring and Enrichment Strategies: FDA Offers More Clinical Trial Guidance

USA – Risk-Based Monitoring and Enrichment Strategies: FDA Offers More Clinical Trial Guidance

Following the release of five guidances to broaden cancer clinical trial eligibility earlier this week, the US Food and Drug Administration (FDA) is out with draft...
Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products Guidance for Industry

USA – Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human...

The purpose of this guidance is to assist industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate the...
EMA Management Board: highlights of March 2019 meeting

Europe – ICH M10 on bioanalytical method validation

This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the...
Australian manufacturing licences and overseas GMP certification

Australia – Updated GMP licence application e-forms

The revised fees and charges model for domestic medicine manufacturers commenced on 1 July 2018. To fully support these changes the TGA needed to update our...
New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

UK – Completed Paediatric Studies – submission, processing and assessment in the event of...

The UK is leaving the EU on 29 March 2019. Securing a deal remains the Government’s top priority. This has not changed. However, the government must...
FDA suggests letting more patients with viral infections into cancer clinical trials

USA – FDA approves a new generic valsartan

Today, the U.S. Food and Drug Administration approved a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats...

NOS PROCHAINES FORMATIONS