USA – FDA releases draft guidance on use-related risk analysis for combo products

The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for...

Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...

EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting. The committee recommended granting a marketing authorisation for Balversa (erdafitinib), for the treatment of adult...

USA – FDA drafts guidance on essential outputs for drug delivery devices

The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors of drug-device combination products in developing “essential drug delivery...

Europe – EMA proposes revamping COVID-19 vaccine guidance for the post-pandemic era

The European Medicines Agency (EMA) is proposing to update its COVID-19 guidances to reflect new developments in the non-clinical and clinical development areas. It...

USA – Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological...

This guidance addresses key aspects of drug delivery performance information for devices, and combination products that include device constituent parts, intended for delivery of...

Europe – Commission authorises Chikungunya vaccine and funds new mosquito eradication programme

The Commission has today authorised the first-ever vaccine against Chikungunya virus - a disease transmitted by infected mosquitoes. While Chikungunya is not endemic in the EU, the...

Europe – Core summary of product characteristics for human plasma-derived and recombinant coagulation factor...

This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products, which are...

Europe – Clinical investigation of recombinant and human plasma-derived factor IX products – Scientific...

This guideline describes the information to be documented when an application for a marketing authorisation for recombinant or human plasma-derived factor IX products is made for use...

Europe – First nasal adrenaline spray for emergency treatment against allergic reactions

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the...

Europe – Positive CHMP opinion on first-in-class medicine to treat pulmonary arterial hypertension

EMA has recommended granting a marketing authorisation in the European Union (EU) for Winrevair (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH), in combination with...