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

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

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

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)

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)

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

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

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 ...

GMP: WHO publishes Draft of an Umbrella Guideline on Process Validation

At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO ...

GMP: FDA issues new Draft Guidance on Elemental Impurities

The ICH Q3D \"Guideline for Elemental Impurities\" was issued in December 2014 and recommended for adoption in the regulations portfolio of the ICH regions Europe, USA and Japan according to the ...

GMP: FDA Draft Guidance on Critical Quality Attributes for Chewable Tablets

On June 16, 2016, the US Food and Drug Administration, FDA, published a draft guidance on \"Quality attribute considerations for chewable tablets\". Comments and suggestions regarding this draft ...

kapitał ludzki

fundusz społeczny

Narodowe Centrum Badań i Rozwoju

innowacyjna gospodarka

rozwój regionalny