USA – Guidance : Male Breast Cancer – Developing Drugs for Treatment

This guidance provides recommendations to sponsors regarding the development and labeling of cancer drugs, including biological products, regulated by the Center for Drug Evaluation...
New Council of Europe resolution to promote pharmaceutical care in Europe

Europe – Update on the review of the CEP application regarding an impurity in...

The EDQM has concluded its investigation following reports that paracetamol manufactured by a specific company holding a certificate of suitability could be contaminated with...

Europe – European Commission reviews impact of orphan, pediatric regulations

The European Commission on Tuesday published the results of a yearslong evaluation of the EU’s orphan and pediatric medicines regulations it says will be...

USA – FDA updates guide for e-submission of trial data

A technical specifications document regarding bioresearch monitoring technical conformance has been updated by the US Food and Drug Administration. The guide provides detailed information for...

Australia – Study affirms safety of human papillomavirus (HPV) vaccine

A new large-scale study that analyses more than 11 years' worth of surveillance data has affirmed the safety of quadrivalent human papillomavirus vaccine (4vHPV)...

USA – FDA guides drug-drug interaction studies for therapeutic proteins

A new draft guidance from the US Food and Drug Administration (FDA) gives industry direction in how to assess drug-drug interactions for therapeutic proteins. The...
New guidance on biologics affects authorized generics

USA – Marketing status notifications: FDA fills in details in final guidance

The US Food and Drug Administration (FDA) on Monday finalized its guidance on marketing status notifications for new and generic drugs, clarifying its expectations...

Europe – Validation issues frequently seen with initial MAAs

This document provides a list of issues frequently seen during the administrative validation of initial MAAs. The document is intended to be used as...

Europe – Post-authorisation : Grouping of Variations – Q & A

This page lists questions that marketing-authorisation holders (MAHs) may have on grouping of variations. It provides an overview of the European Medicines Agency's position on issues that...

USA – Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those...

NOS PROCHAINES FORMATIONS