MHRA: Maintenance of Active Pharmaceutical Ingredient (API) and other sites named on marketing authorisations

Marketing and manufacturing authorisation holders are reminded that as all sites named on approved marketing authorisations (MAs) can be used for the activity they have been registered for without ...

MHRA: Adverse drug reactions: Update on Anonymised Single Patient Reports (ASPRs): July 2010

The MHRA has implemented a series of changes to the logic which defines which marketing authorisation holders (MAHs) receive ASPRs/Individual Case Safety Reports (ICSRs). It is expected that these ...

FDA: ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents

Draft Recommendation for the Revision of the Permitted Daily Exposure for Cumene According to the Maintenance Procedures for Q3C Impurities: Residual Solvents ...

FDA: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application

This guidance is intended to provide information for those using radioactive drugs for certain research purposes to help determine whether research studies can be conducted under 21 CFR 361.1, ...

FDA: Label Comprehension Studies for Nonprescription Drug Products

The Food and Drug Administration (FDA) sometimes requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. This ...

EMA: Scientific guideline: Questions & Answers: positions on specific questions addressed to the EWP therapeutic subgroup on pharmacokinetics

In the context of assessment procedures, the Therapeutic Subgroup on Pharmacokinetics of the Efficacy Working Party (EWP-PK subgroup) is occasionally consulted by the CHMP or, following ...

EMA: Regulatory and procedural guideline: Centralised procedures and MRL procedures. Recommended submission dates for new and extension applications

Centralised procedures and MRL procedures Recommended submission dates for new and extension applications ...

EMA: Scientific guideline: Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg)

This Guideline describes the information to be documented when an application is made for a marketing authorisation for a human normal immunoglobulin for intravenous use (IVIg). The guidance ...

EMA: Clinical efficacy and safety: Radiopharmaceuticals and Diagnostic Agents

Clinical efficacy and safety: Radiopharmaceuticals and Diagnostic Agents ...

EMA: Safety monitoring of medicines: overview of the Agency’s activities

Before a medicine is authorised for use, any experience of its safety and efficacy is limited to its use in clinical trials. Therefore, at the time of a medicine’s authorisation, it will only ...

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