Europe – EU regulators offer new guidance on complex clinical trials
European regulators published a question and answer document that they hope will give more clarity on how complex clinical trials (CCT) should be conducted. The document...
UK – AstraZeneca’s Evusheld not recommended by NICE for COVID-19 prevention
In new draft guidance, NICE explained that there is not enough evidence of Evusheld's effectiveness against current SARS-CoV-2 variants in the UK and those...
UK – Pholcodine-containing cough and cold medicines: withdrawal from UK market as a precautionary...
Pholcodine-containing cough and cold medicines are being withdrawn from the UK market as a precaution following a review which found that their benefits...
France – Evaluer le circuit des Médicaments de thérapie Innovante (MTI)
Les nombreuses spécificités des MTI (médicaments stériles, OGM, stockage cryogénique…) nécessitent une rigueur pharmaceutique et une logistique robuste pour permettre une prise en charge...
Europe – EMA recommends withdrawal of pholcodine medicines from EU market
EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive (dry) cough and,...
USA – FDA draft guidance aims to help sponsors develop drugs for radiation exposure
The US Food and Drug Administration (FDA) on 19 April issued draft guidance that encourages sponsors to have “early and ongoing” communication with the...
USA – FDA issues final guidance on nicotine replacement therapy
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Monday issued a final guidance to assist sponsors interested...
UK – NICE recommends Pfizer’s rimegepant for preventing episodic migraine attacks
The National Institute for Care and Excellence (NICE) has announced that it has recommended an oral treatment for the prevention of episodic migraines for...
Europe – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This document considers testing and evaluation of the viral safety of biotechnology products derived from characterised cell lines of human or animal origin. It outlines...
Europe – First treatment for children with Progeria or progeroid like syndromes (rare premature...
EMA has recommended granting a marketing authorisation in the European Union (EU) under exceptional circumstances for Zokinvy (lonafarnib), a treatment for patients with a genetically confirmed diagnosis of...
