Europe – ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms –...
ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms...
Canada – Drug and medical device databases
This list of Health Canada's drug and medical device databases briefly describes the information available in each database. It does not provide an in...
UK – NICE endorses Neuraxpharm’s ublituximab for treating MS
Neuraxpharm Group has announced that the National Institute for Health and Care Excellence (NICE) has recommended ublituximab (BRIUMVI®) for the treatment of relapsing-remitting multiple...
UK – NICE recommends Immunocore’s Kimmtrak as first drug for aggressive eye cancer
Kimmtrak will now be available on the NHS in England to treat HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma, with more than 100...
USA – Researchers suggest FDA needs authority to require pediatric studies for orphan drugs
The US Food and Drug Administration (FDA) may need greater authority to require pediatric clinical studies for drugs, including orphan drugs, according to a...
USA – FDA finalizes BIMO electronic submission guidance
The US Food and Drug Administration (FDA) has finalized guidance for sponsors on electronically submitting data on drugs and biologics that the agency will...
USA – Accelerated approval: FDA revises guidance to reflect revised withdrawal procedures
The US Food and Drug Administration (FDA) on Thursday issued draft guidance that would replace the accelerated approval portion of its broader guidance covering...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024
Doxycycline: currently available evidence not supporting link with risk of suicidality
EMA’s safety committee (PRAC) has concluded that the currently available evidence is not sufficient...
USA – FDA recommends collecting ovarian toxicity data in cancer drug trials
The US Food and Drug Administration (FDA) is proposing sponsors collect ovarian toxicity data during cancer drug development. The agency said that cancer drugs...
France – Tramadol et codéine devront être prescrits sur une ordonnance sécurisée
Tramadol et codéine sont des médicaments opioïdes. Les risques de mésusage, de dépendance, d’abus et de surdosage qui leur sont associés sont importants. Afin...
