FDA Singles Out Three Drug Substances to Not be Compounded

USA – FDA Singles Out Three Drug Substances to Not be Compounded

The US Food and Drug Administration (FDA) on Monday identified three bulk drug substances that it is proposing to not include in a list...
FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

USA – FDA Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

The US Food and Drug Administration (FDA) on Tuesday released two new draft Q&A guidance documents on biosimilar development and the deemed to be...
Change in the classification of certain glucosamine products

Europe – Change in the classification of certain glucosamine products

Following a Court of Appeal Judgment in 2016, the Medicines and Healthcare products Regulatory Agency (MHRA) started a review of the classification of glucosamine...
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018

Europe – Regulatory information – adjusted fees for pharmacovigilance applications from 18 October 2018

Pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing authorisation holders increase by 1.7% as of 18 October 2018, to reflect the inflation rate...
FDA updates endpoint guidance for cancer trials

USA – New Product-Specific Guidances Focus on Drugs Without Generic Competition

The US Food and Drug Administration (FDA) on Tuesday issued 63 new and revised draft product-specific guidances detailing its expectations for companies looking to...
Sanofi’s Cablivi cleared for rare bleeding disorder

Europe – Sanofi’s Cablivi cleared for rare bleeding disorder

The European Commission has authorised Cablivi (caplacizumab) as the first therapeutic specifically indicated for the treatment of adults experiencing an episode of aTTP. The condition...
NICE rejects Genzyme’s Caprelsa for medullary thyroid cancer

UK – NICE rejects Genzyme’s Caprelsa for medullary thyroid cancer

According to the Institute, while Caprelsa (vandetanib) may delay the disease getting worse compared with best supportive care, “but the benefit is uncertain”. Also, it...
MHRA responds to consultation on Brexit no-deal proposals

UK – MHRA responds to consultation on Brexit no-deal proposals

There is ongoing concern that a no-deal Brexit may limit the availability of medicines in the UK, but pharmaceutical companies are “doing everything in...
Reflection paper on the qualification of non-genotoxic impurities

Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and...

This document updates and replaces the Annex previously included in the Guideline CPMP/463/00 Rev. 1. It is an integral part of the European Commission guideline...
Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Europe – Guideline on the reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation

Executive summary A growing number of regulatory submissions include physiologically based pharmacokinetic (PBPK) models that require the use of specialised software platforms. While PBPK modelling...

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