USA – AAM seeks clarity, leeway in BA/BE studies guidance
The Association for Accessible Medicines (AAM) wants the US Food and Drug Administration (FDA) to clarify what its expectations of sponsors of bioavailability (BA)...
USA – Experts, FDA officials discuss future of clinical trials
Officials from the US Food and Drug Administration (FDA) and participants from the JAMA Summit on clinical trials recently highlighted the relationship between the...
France – Acide hyaluronique : les autorités sanitaires renforcent la réglementation en rendant la...
Issu de travaux de concertation menés par la Direction générale de la Santé, ce décret vise à mieux protéger la population des injections illégales...
Europe – Procedural advice on paediatric applications
The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective is to improve the health of children...
UK – New restrictions on puberty blockers
The government has today introduced regulations to restrict the prescribing and supply of puberty-suppressing hormones, known as ‘puberty blockers’, to children and young people under 18 in...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its May 2024 meeting.
The CHMP recommended granting a marketing authorisation under exceptional circumstances for Adzynma* (rADAMTS13) an enzyme replacement therapy indicated...
Europe – First vaccine to protect adults from Chikungunya
EMA has recommended granting a marketing authorisation in the European Union (EU) for Ixchiq, the first vaccine in the EU to protect adults 18 years and...
Europe – New gene therapy treatment for haemophilia B
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe haemophilia B in...
USA – FDA plans to release AI drug development guidance this year
The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to...
Europe – Commission approves up to €1 billion of State aid by six Member...
The European Commission has approved, under EU State aid rules, the first Important Project of Common European Interest (‘IPCEI') to support research, innovation and...
