USA – FDA issues draft guidances covering BIMO inspections
The US Food and Drug Administration (FDA) has issued two draft guidances on bioresearch monitoring (BIMO) inspections. The first covers information to assist the...
France – L’agence du médicament sonne l’alarme au sujet de réactions allergiques associées à...
L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) a observé une « augmentation constante du nombre de déclarations de réactions allergiques graves...
International – ICH Q12 IWG “Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management »
L'ICH Q12 (IWG) "Regulatory and Technical Considerations for Pharmaceutical Product Lifecycle Management" Module 8 Training Material est désormais accessible sur le site web de...
UK – Brainomix’s AI-enabled stroke software endorsed by NICE
The National Institute of Health and Care Excellence (NICE) has issued guidance endorsing the use of Brainomix’s artificial intelligence (AI)-enabled software, Brainomix 360, to...
Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR)...
UK – NICE recommendation for new Alexion PNH treatment
Alexion, AstraZeneca Rare Disease, announced that the National Institute for Health and Care Excellence (NICE) has given a positive recommendation for Voydeya (danicopan).
This first-in-class,...
UK – Nitrosamines impurities in medicines
The Medicines and Healthcare products Regulatory Agency (MHRA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and...
USA – FDA releases guidance on labeling of drug use-related software outputs
The US Food and Drug Administration (FDA) has released draft guidance with considerations on how to include software outputs of drug use-related software in...
USA – Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry
This guidance provides recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small-molecule drug or...
USA – Pharmaceutical industry wants FDA to extend deadline for testing novel nitrosamines
Industry stakeholders urged the US Food and Drug Administration (FDA) to postpone its October 2023 deadline for testing drug products for novel nitrosamines, saying...
