USA – FDA revises guidance on delaying, denying, limiting or refusing an inspection
On Dec. 15, 2022, the FDA released for public comment Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection Revision 1....
USA – FDA finalizes neurodegenerative disease gene therapy guidance
The US Food and Drug Administration (FDA) last week finalized guidance to assist sponsors developing human gene therapy (GT) products for neurodegenerative diseases. In...
Europe – Start of rolling review for adapted Comirnaty COVID-19 vaccine
EMA has started a rolling review for a version of Comirnaty adapted to provide better protection against a specific variant or variants of SARS-CoV-2,...
Brazil – ANVISA approves skinny labeling in Brazil
On December 6, the Board of Directors (DICOL) of the Brazilian Food & Drug Agency (ANVISA) passed new regulations accepting an exemption to allow...
France – Forfait innovation : une 1ère technologie de santé inscrite au remboursement par...
Mis en place en 2009 et piloté par le ministère chargé de la santé, le forfait innovation est un dispositif dérogatoire et temporaire de...
USA – Study: Few FDA-approved targeted cancer drugs meet ESMO benefit benchmarks
Fewer than one-third of molecularly targeted cancer drugs recently approved by the US Food and Drug Administration (FDA) meet established European benchmarks for clinical...
USA – FDA details policy on facility reclassification requests under GDUFA III
The US Food and Drug Administration (FDA) recently issued a manual of policies and procedures (MAPP) on the procedures it will follow in following...
Europe – EMA takes further steps to address critical shortages of medicines in the...
Today, EMA published details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). This voluntary mechanism allows Member States to...
Europe – Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimise risk...
EMA’s safety committee (PRAC) has recommended new measures to minimise the risk of meningioma with medicines containing nomegestrol or chlormadinone, which are used for...
France – Avis relatif à la couverture des besoins de la population générale en...
Le HCSP évalue la couverture des besoins nutritionnels de la population pour le fer et la vitamine D dans le cadre de la mise...
