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RAPS: FDA Makes Drug Safety Labeling Change Information Easier to Access

08.09.2016
The US Food and Drug Administration (FDA) on Thursday announced the safety labeling changes (SLC) program will be managed by its Center for Drug Evaluation and Research’s (CDER’s) Office of ...

GMP: EMA - requirements for quality documentation concerning biological investigational medicinal products

08.09.2016
Already in 2012, the European Commission published a guideline on the quality documentation for IMP in clinical trials. Now on 23 June, the EMA issued a draft \"Guideline on the requirements for ...

FDA: E17 General Principles for Planning and Design of Multi-Regional Clinical Trials This

08.09.2016
With the increasing globalisation of drug development, it has become important that data from multi-regional clinical trials (MRCTs) can be accepted by regulatory authorities across regions and ...

FDA: Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation

08.09.2016
The purpose of this guidance is to assist sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development. Specifically, this guidance addresses ...

EMA: EU collaboration strengthens safety monitoring of medicines

10.08.2016
European Commission publishes three-year report on implementation of pharmacovigilance legislation. Closer collaboration between the European Medicines Agency (EMA), the European Commission and ...

EMA: Draft vandetanib film-coated tablets 100 and 300 mg product-specific bioequivalence guidance

10.08.2016
This document provides product-specific guidance on the demonstration of the bioequivalence of vandetanib. ...

EMA: Draft guideline on good pharmacovigilance practices (GVP) - Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2)

10.08.2016
This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter 3 of Title II of Regulation (EC) No 726/2004, which are applicable to competent ...

EMA: Draft guideline on good pharmacovigilance practices (GVP) - Module IX – Signal management (Rev. 1)

10.08.2016
Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal ...

EMA: Draft guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

10.08.2016
Monitoring of databases of spontaneously reported suspected adverse reactions (in the format of individual case safety reports (ICSRs), see GVP Module VI) is an established method of signal ...

FDA: Ulcerative Colitis: Clinical Trial Endpoints

10.08.2016
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of ulcerative colitis (UC) in adult and pediatric patients. Specifically, this guidance ...