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The US Food and Drug Administration’s (FDA) has issued a trio of draft guidance documents that aim to promote greater participation and diversity in...
Europe – EMA adopts first list of critical medicines for COVID-19
On 7 June 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of critical medicines for the COVID-19 public health emergency . The medicines included in the...
International – ICH E11A: Pharma groups want more information on data extrapolation, pediatric biomarkers
Two US pharmaceutical industry groups note that they are generally supportive of the International Council for Harmonization (ICH) guideline on pediatric extrapolation in drug...
Europe – New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome
On 29 September 2022, EMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure (severe breathing difficulties that may be...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its October 2022 meeting.
The CHMP recommended granting a marketing authorisation for Dengue Tetravalent...
UK – MHRA launches new conflicts of interest code of practice for independent advisors
The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing a new, single code of practice for all its scientific advisory committees, to ensure...
USA – Patients with incurable cancer should be included in trials for new therapies
The US Food and Drug Administration (FDA) has issued final guidance on the inclusion of patients with incurable cancers in clinical trials for investigational...
Uk – NICE recommend’s use of Leo Pharma’s Adtralza
The National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document recommending Leo Pharma’s Adtralza (tralokinumab), Rinvoq (upadacitinib) and Cibinqo...
International – ICH details milestones reached on guidelines after Athens meeting
The International Council for Harmonisation (ICH) announced it has reached several milestones over the past year, including advancing guidelines on validating analytical procedures for...
USA – FDA issues draft guidance on dosage and administration labeling
The US Food and Drug Administration (FDA) has issued draft guidance aimed at improving the consistency of information in the dosage and administration section...
