Europe – Core summary of product characteristics for human plasma-derived and recombinant coagulation factor...
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products, which are...
Europe – Global regulators strengthen efforts to ensure continuous availability of safe and high-quality...
On 20 July 2023, a virtual workshop was held to discuss progress made in the development of a PQ KMS. The workshop was jointly organised by...
USA – FDA sets acceptable intake limits for nitrosamines in drugs
The US Food and Drug Administration (FDA) on Friday issued a final guidance that outlines a framework for predicting the mutagenic and carcinogenic risk...
International – ICH M12: Pharma industry wants clarity on rifampin dosing, more information on...
The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use...
Europe – Report: How EU ensured safety of medicines during COVID-19
Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders...
USA – Generic drugmakers seek clarity on pre-submission facility correspondence
Drugmakers want clarifications on an updated draft guidance the US Food and Drug Administration (FDA) recently released on pre-submission facility correspondence (PFC) for generic...
UK – NICE recommends Takeda’s Ninlaro triplet regimen
Therapy involves patients living with relapsed or refractory multiple myeloma
Takeda has announced that the National Institute for Health and Care Excellence (NICE) has recommended...
International – ICH advances guidelines on selective reporting of safety data, viral safety
The International Council for Harmonisation (ICH) recently announced the adoption of its E19 guideline, which outlines a risk-based approach for collecting safety data for...
USA – HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules
The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year....
USA – Stakeholders provide feedback on FDA draft guidance on drug development for early...
Guidance for developing drugs to treat early Alzheimer’s disease should focus on factors such as cognitive changes and brain atrophy, according to comments submitted...
