International – ICH Guideline Q5A(R2) on viral safety evaluation of biotechnology products derived from...
This guideline concerns the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should be submitted in marketing...
International – ICH guideline Q3C (R8) on impurities: guideline for residual solvents Step 5
The objective of this guideline is to recommend acceptable amounts for residual solvents in
pharmaceuticals for the safety of the patient. The guideline recommends use...
France – Avis de sécurité des Hospices civils de Lyon sur le LAP Easily
Les Hospices civils de Lyon (HCL) ont émis le 29 décembre un avis de sécurité sur le logiciel d'aide à la prescription (LAP) Easily...
UK – Sobi receives NICE recommendation for Zynlonta in two non-Hodgkin lymphomas
The CD19-directed antibody-drug conjugate (ADC) has specifically been recommended for use in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or high-grade...
USA – Pharma groups: FDA is exceeding its authority in risk management plan guidance
The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of...
USA – Study: Certain cancer drugs saw widespread use before accelerated approval withdrawal
In the period between when three accelerated approval (AA) drugs received approval from the US Food and Drug Administration (FDA) for oncology indications and...
USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR...
The Department of Health and Human Services (HHS) recently published the fall 2023 unified agenda for the US Food and Drug Administration (FDA) that...
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...
International – Regulators, industry tout new approach for benefits-risk assessments
Regulators and industry representatives said that a new international guideline for evaluating the benefit-risk profile of new and marketed drugs developed by the Council...
UK – NICE nod for Darzalex with lenalidomide and dexamethasone
The Janssen Pharmaceutical Companies of Johnson & Johnson has announced that the National Institute for Health and Care Excellence (NICE) has recommended Darzalex –...
