International – ICH adopts Q13 guideline on continuous manufacturing
The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing....
USA – FDA updates statistical approaches for assessing bioequivalence
The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies...
USA – FDA revises ANDA facility correspondence draft guidance
The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 November –...
EMA recommends withdrawal of pholcodine medicines from EU market
EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults...
Europe – EMA recommends withdrawal of pholcodine medicines from EU market
EMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive (dry) cough and,...
Europe – Respiratory vaccination candidate tested in German hospitals
Researchers are investigating whether the vaccine candidate VPM1002 – originally developed against tuberculosis by scientists at the Max Planck Institute for Infection Biology, Berlin...
International – Un médicament fait espérer l’éradication de la maladie du sommeil
L’éradication de la « maladie du sommeil » – ou trypanosomiase africaine – serait-elle à portée de main ? C’est l’espoir que suscitent les résultats d’un essai...
USA – Industry groups seek changes to nonprescription drug access proposal
Drugmakers, pharmacists and others are calling for flexibility in the US Food and Drug Administration’s (FDA) proposed rule on requirements for nonprescription drug products...
Singapore – Singapore’s HSA finalizes LDT guidelines
Singapore’s Health Sciences Authority (HSA) has finalized guidance intended to help clinical laboratories understand the regulatory requirements for tests they develop internally.
To date, HSA...
International – mRNA revolutionized the race for a Covid-19 vaccine. Could cancer be next?
The unprecedented success of messenger RNA vaccines against the coronavirus is raising hopes that the technology could lead to new and better vaccines against...
