USA – Biosimilar labeling guidance suggests cutting interchangeability details from labels
In new draft guidance on biosimilar labeling, the US Food and Drug Administration (FDA) recommends removing details about interchangeability from the labels of these...
France – Traitement de l’acné sévère : mieux faire connaître les risques associés à...
Pour renforcer l’information sur les effets indésirables liés à l’isotrétinoïne orale et les précautions à adopter en cas de traitement, un dossier thématique est...
UK – NICE issues final draft recommending Novartis’ Scemblix to treat chronic myeloid leukaemia
NICE’s decision will allow access to an innovative treatment channel which will help to address an unmet need for eligible people in England and...
Europe – EMA alerts EU patients and healthcare professionals to reports of falsified Ozempic...
The European Medicines Agency has been notified by relevant national competent authorities that pre-filled pens falsely labelled as the diabetes medicine Ozempic (semaglutide, 1 mg, solution...
USA – Most FDA warning letters this year from onsite inspections
A US Food and Drug Administration (FDA) official said that most warning letters issued for drug good manufacturing practice (GMP) issues in fiscal year...
Europe – Addendum to the guideline on the evaluation of medicinal products indicated for...
This addendum to the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 3) has been developed to...
USA – Guidance details review process for pediatric research not approvable by an IRB
The US Food and Drug Administration (FDA) last week issued draft guidance offering insights to sponsors and institutional review boards (IRBs) on the process...
USA – Industry calls for revisions in FDA’s CGT manufacturing change guidance
Pharmaceutical industry and regenerative therapy groups want the US Food and Drug Administration (FDA) to take a more nuanced approach in guidance on reporting...
USA – FDA addresses use of remote interactive evaluations in post-pandemic era
Draft guidance from the US Food and Drug Administration (FDA) outlines the agency’s approach for remote interactive evaluations (RIE) of pharmaceutical and biologics facilities...
USA – Generic manufacturers call for changes to list of major deficiencies
Generic drug manufacturers are urging the US Food and Drug Administration (FDA) to revise its guidance on amendments to Abbreviated New Drug Applications (ANDA)...
