USA – FDA issues draft guidance on post-warning letter meetings under GDUFA III
The US Food and Drug Administration (FDA) has published a new draft guidance to help sponsors navigate the post-warning letter meeting process as specified...
UK – MHRA approves Pfizer/BioNTech’s adapted COVID-19 vaccine (Comirnaty) that targets Omicron XBB.1.5
Approval has today been granted by the Medicines and Healthcare products Regulatory Agency (MHRA) for an adapted Pfizer/BioNTech COVID-19 vaccine that targets the Omicron...
UK – Guidance published on the new international regulatory recognition routes for medicines approvals
Following announcement in May of the new scheme to replace the current EC Decision Reliance Procedure (ECDRP) on 1 January 2024, this guidance informs the sector on how...
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...
