UK – NICE recommends Chiesi’s Elfabrio for adults with Fabry disease
The NICE committee concluded that the treatment would be an additional ERT for patients with and without an amenable mutation and was a relevant...
International – E-labeling and digital transformation in healthcare
This article examines the regulations for electronic labeling (e-labeling) for prescription drugs and medical devices in Japan, Brazil, Singapore, the EU and US, Canada,...
USA – FDA publishes additional guidances on delay of enforcing DSCSA electronic tracking requirements
The US Food and Drug Administration (FDA) published two additional guidances with immediate effect that provide more details for trading partners on the one-year...
Europe – PRAC recommends new measures to avoid topiramate exposure in pregnancy
Further restrictions on use; pregnancy prevention programme to be put in place
EMA’s safety committee (PRAC) recommends new measures to avoid exposure of children to...
Europe – COVID-19: Commission authorises adapted COVID-19 vaccine for Member States’ autumn vaccination campaigns
The Commission has authorised the Comirnaty XBB.1.5-adapted COVID-19 vaccine, developed by BioNTech-Pfizer. This vaccine marks another important milestone in the fight against the disease....
USA – FDA finalizes guidance on real-world evidence in drug approvals
The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of real-world data (RWD) and real-world evidence (RWE) in...
Europe – Comirnaty: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
EMA’s human medicines committee (CHMP) has recommended authorising an adapted Comirnaty vaccine targeting the Omicron XBB.1.5 subvariant.
The vaccine – known as Comirnaty Omicron XBB.1.5...
UK – NHS world first rollout of cancer jab that cuts treatment time by...
Following the green light from the Medicines and Healthcare products Regulatory Agency (MHRA), the NHS in England will be the first health system in...
USA – Psychedelic drug trial guidance: Commenters see vital role for psychotherapy
Commenters on the US Food and Drug Administration’s (FDA) first guidance on clinical investigations and drug development programs for psychedelic drugs raised concerns about...
UK – Nitrosamines impurities in medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and...
