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USA – FDA explains when it will rescind breakthrough designations
The US Food and Drug Administration (FDA) on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy designation (BTD) during its...
UK – UK to strengthen regulation of medical devices to protect...
MHRA to reform medical devices regulation to improve patient health and encourage innovation
The UK is seizing the opportunities provided by leaving the...
Europe – Upcoming changes to REACH information requirements
The update of the REACH annexes clarifies the information companies need to submit in their registrations and makes ECHA’s evaluation practices more transparent and...
International – Enanta takes legal action against Pfizer over Paxlovid patent...
The company specialises in developing small molecule treatments for liver diseases and infection. Among these drugs, Enanta has produced therapies to address respiratory syncytial...
WEBINAR – Impuretés dans le principe actif et le médicament
Qu’attendre de cette formation (Objectif) :
Une approche cohérente et compréhensive relative aux points clés suivants :
• Les principales exigences des guidelines ICH Q3A, Q3B...
