Europe – New general chapter on implementation of pharmacopoeial procedures published in the 11th...

A new general chapter, Implementation of pharmacopoeial procedures (5.26), has just been published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). The text was adopted...

USA – FDA offers new guidance on therapeutic equivalence evaluations

In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment...
ANSM – Comité d’interface du 6 Février – EUDAMED

France – Topiramate : risque de troubles neurodéveloppementaux chez les enfants exposés in utero...

Une étude publiée dans le JAMA Neurol portant sur le risque de troubles neurodéveloppementaux chez les enfants exposés aux antiépileptiques pendant la grossesse a mis en...

USA – Medtech groups want more time to implement FDA’s QMSR rule

Medical device lobby groups say they support the US Food and Drug Administration’s plan to align its Quality System Regulations (QSR) with the international...

USA – FDA officials offer advice on gene therapy trials

Officials from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) asserted...
New guidance on biologics affects authorized generics

USA – FDA seeks feedback on artificial intelligence in drug manufacturing

The US Food and Drug Administration (FDA) is soliciting feedback on how to incorporate artificial intelligence (AI) and advanced manufacturing techniques into the current...

Europe – EMA recommendation paper: Safety, data integrity key to decentralized trial conduct

The European Medicines Agency (EMA), European Commission (EC), and Heads of Medicines Agencies (HMA) recently acknowledged the growing role of decentralized elements in the...
Ajovy bags NICE approval

UK – Bristol Myers Squibb’s Opdivo recommended by NICE for rare gastroesophageal cancers

Specifically, NICE’s recommendation is extended to patients with untreated HER2-negative, advanced or metastatic gastric, gastro-oesophageal junction or oesophageal adenocarcinoma if the tumours express PD-L1...
WHO drafts guidance for pharma supply chain tracking

International – WHO proposes updated excipient GMPs in wake of contaminated cough syrup

The World Health Organization (WHO) recently proposed updated guidance to assist pharmaceutical manufacturers in assessing the quality of excipients after child deaths were reported...
NICE ‘OK’ for Lynparza

UK – AstraZeneca’s heart failure treatment recommended by NICE for expanded use

Forxiga, sold as Farxiga in certain markets, has previously been recommended by NICE as a treatment option for HF patients with reduced ejection fraction...