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EMEA: Overview of comments

10.06.2009
Overview of comments received on the draft guideline on the specification limits for residues of metal catalysts ...

EMEA: Overview of comments

10.06.2009
Overview of comments received on the draft guideline on the carcinogenicity evaluation of medicinal products for the treatment of HIV infection ...

EMEA: Overview of comments

10.06.2009
Overview of comments received on the draft guideline on the need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications ...

MHRA: Special Mail 5: Frequently Asked Questions (version 2.1 - June 2009)

10.06.2009
The guidance in Special MAIL 5 includes that for submitting new MA applications, MA variations and Clinical Trial applications. For MA applications and variations, it is expected that this ...

FDA: Q8(R1) Pharmaceutical Development Revision 1

10.06.2009
This guidance is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that published in May 2006. The Q8 parent guidance is revised to add an annex, which provides ...

EMEA: CVMP Guideline on Eudravigilance veterinary XML Schema Definition (XSD) (CVMP adopted March 2004) - Version 2.2.1

09.06.2009
This document describes the electronic standard to exchange safety reports on adverse reactions to veterinary medicinal products. It is based on the EMEA Guieline Data elements for the electronic ...

EMEA: Draft documents for Community Herbal Monograph

09.06.2009
Community Herbal Monograph on Valerianae radix and Lupuli flos Valeriana officinalis L., redix and Humulus lupulus L., flos (valerian root and hop strobiles) ...

FDA: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use With Drugs and Biological Products

09.06.2009
FDA is providing this draft guidance document to assist industry in developing technical and scientific information to support a marketing application for a pen, jet, or related injector device ...

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

09.06.2009
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: Medication Guides — Adding a Toll-Free Number for Reporting Adverse Events

09.06.2009
This guidance explains: the content and format of the side effects statement, where in the Medication Guide to add the side effects statement, and how to report to the Agency that ...