USA – FDA draft guidance focuses on postapproval trial diversity data
Sponsors can employ several postmarketing strategies to beef up safety and efficacy data on populations that were under-represented in initial clinical trials of drugs...
USA – FDA finalizes guidance on standards for tracing products through supply chain
The US Food and Drug Administration (FDA) will allow trading partners to track drug products through the pharmaceutical supply chain using portals and email...
USA – FDA issues draft guidance on post-warning letter meetings under GDUFA III
The US Food and Drug Administration (FDA) has published a new draft guidance to help sponsors navigate the post-warning letter meeting process as specified...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....
