USA – FDA issues three guidances to expand cancer clinical trial eligibility
The US Food and Drug Administration’s (FDA) has issued a trio of draft guidance documents that aim to promote greater participation and diversity in...
USA – FDA issues long-awaited LDT final rule
After years of jostling with industry, failed legislative efforts, and some false starts, the US Food and Drug Administration (FDA) has unveiled its plan...
Europe – Guidance : Anonymisation of personal data and assessment of commercially confidential information...
This document gives general guidance to applicants/marketing authorisation holders (MAHs) on the retention/removal of personal data (PD) and identification of commercially confidential information (CCI)...
USA – FDA updates guidance on promotional labeling and advertising of biosimilars
The US Food and Drug Administration (FDA) has published revised guidance on promotional labeling and advertising for prescription biosimilar drugs and their reference products.
The...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Eight new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.
The CHMP recommended granting a marketing authorisation for Altuvoct* (efanesoctocog alfa), for...
UK – 170,000 people in England to have further treatment choice for preventing migraine...
Also called Aquipta and made by AbbVie, NICE has recommended atogepant as an option for preventing chronic and episodic migraines in adults who have had at least...
UK – Children and teenagers with an aggressive form of brain cancer set to...
A new targeted drug combination treatment, described as a ‘step-change in care’ for children and young people with an aggressive form of brain cancer,...
USA – CBER chief on remote work, CRISPR-Cas9, and rare disease gene therapy accelerated...
The use of CRISPR-Cas9 gene editing technology has potential to transform the field of gene therapy through its simple and cost-effective delivery mechanism, said...
Europe – EMA seeks feedback on quality, therapeutic equivalence of inhaled drugs
The European Medicines Agency (EMA) has released two draft guidelines for consultation on inhaled medicines. One covers the pharmaceutical quality of inhalation and nasal...
Europe – New recommendations to strengthen supply chains of critical medicines
These recommendations have been developed by EMA’s Medicines Shortages Steering Group (MSSG) and will facilitate the availability and supply of critical human medicines for which vulnerabilities...
