Europe – Use of real-world evidence in regulatory decision making – EMA publishes review...
Real-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments...
USA – FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs
Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Two new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended two medicines for approval at its June 2023 meeting.
The committee recommended granting a marketing...
USA – Pharmacogenomic data guidance: Industry objects to reporting exploratory studies
An industry group representing pharmaceutical and biotechnology companies is asking the US Food and Drug Administration (FDA) not to require the reporting of results...
USA – FDA’s drug quality report card details enforcement trends, increased inspections in 2022
In its latest State of Pharmaceutical Quality report, the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) cited an increase in...
Europe – ACT EU: creating a better environment for clinical trials through collaboration
The Accelerating Clinical Trials in the EU (ACT EU) initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU)....
USA – FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne...
Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of...
USA – Generic drug lobby details extent of US shortages, offers possible solutions
The Association for Accessible Medicines (AAM) has issued a white paper urging the US Food and Drug Administration (FDA) and other policymakers to adopt...
Europe – Report: How EU ensured safety of medicines during COVID-19
Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders...
USA – FDA pilot aims to boost transparency for oncology tests
The US Food and Drug Administration (FDA) is looking for up to nine drugmakers to join a pilot program intended to improve transparency for...
