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FDA: Regulatory Classification of Pharmaceutical Co-Crystals

07.12.2011
This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research’s current thinking on the ...

GMP: New Concept Paper of the European Commission on the Use of Safety Features against Falsified Medicinal Products

07.12.2011
On 18 November 2011, the European Commission published a concept paper entitled \"Delegated Act on the Detailed Rules for a Unique Identifier for Medicinal Products for Human Use, and its ...

EMA: Fees for type IA variations to be due at start of procedure

07.12.2011
The European Medicines Agency is informing marketing-authorisation holders that from 1 January 2012, fees for type IA variations will be due at the start of the 30-day procedure ...

EMA: Qualification opinion of Alzheimer’s disease novel methodologies/biomarkers in predementia AD clinical trials

07.12.2011
In follow-up to the positive Qualification Opinion on the use of cerebrospinal fluid (CSF) biomarkers in predementia AD adopted on 14-Apr-2011 (EMA/CHMP/SAWP/102001/2011), BMS is requesting an ...

EMA: Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

30.11.2011
This document provides guidance on the data requirements to support authorisation of combined vaccines and a claim for the use of two or more IVMPs, each with its own separate marketing ...

EMA: Guideline on the design of studies to evaluate the safety and efficacy of fish vaccines

30.11.2011
This document provides information on items to be considered in the design and conduct of studies to support the safety and efficacy of immunological veterinary medicinal products (IVMPs) in ...

FDA: Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic Radiopharmaceuticals

30.11.2011
The objective of this guidance is to provide recommendations to industry for designing nonclinical late radiation toxicity studies to determine potential late radiation effects of therapeutic ...

GMP: USP publishes First Ten Quality Standards in New Medicines Compendium

30.11.2011
On November 28, 2011 the United States Pharmacopeial Convention (USP) published the first ten standards for the USP Medicines Compendium (MC). The MC is a free, online source of public standards ...

EMA: Overview of comments received on \'Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1)

24.11.2011
Interested parties (organisations or individuals) that commented on the draft document as released for consultation. ...

EMA: Appendix IV of the Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) - adopted

24.11.2011
This Appendix contains a set of template tables to assist applicants in the preparation of Module 2.7.1 providing guidance with regard to data to be presented. Furthermore, it is anticipated that ...