France – « Contre la résistance aux antibiotiques, la recherche et la production publiques...

La Journée mondiale de prévention de l’antibiorésistance qui s’est tenue le 18 novembre a alerté sur cette menace sanitaire croissante considérée par les instances internationales...

Europe – EMA recommends restricting use of cancer medicine Rubraca

EMA’s human medicines committee, CHMP, has recommended that Rubraca (rucaparib camsylate) should no longer be used as third-line treatment for cancers of the ovary, fallopian...

USA – FDA releases guidance on compounding beta-lactam products in shortage

The US Food and Drug Administration (FDA) has released a new guidance with immediate effect outlining its enforcement policy for preparation of certain beta-lactam...

USA – FDA final guidance clarifies whole slide imaging expectations in nonclinical toxicology studies

The US Food and Drug Administration (FDA) on Tuesday issued final guidance on the use of whole slide imaging in nonclinical toxicology studies. The...

Europe – New measures to minimise risk of meningioma with medicines containing nomegestrol or...

EMA’s human medicines committee (CHMP) has endorsed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that the benefits of medicines containing nomegestrol or...

USA – FDA offers guidance on fit-for-purpose clinical outcome assessments

The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the...

Europe – Further measures to identify and address medicine shortages during public health emergencies...

On 7 July 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the list of the main therapeutic groups of medicines used in emergency care, surgery and intensive...

Europe – EMA confirms recommendation for non-renewal of authorisation of Duchenne muscular dystrophy medicine...

Update as of 21 May 2024 The European Commission has asked the CHMP to review its January opinion on the renewal of the marketing authorisation for Translarna. The CHMP will now consider the...

USA – FDA issues final guidance on ANDA CRL, Orange Book

The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to...
TGA Creates Advertising Guidance for Providers of Cell and Tissue Products

Australia – Nitrosamine risk assessment in Category 1 prescription medicine registration applications

Sponsors need to be aware of the global issue relating to nitrosamine impurities in medicines. In particular, they should be familiar with the known...