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FDA: E7 Studies in Support of Special Populations

19.11.2009
Draft Guidance E7 Studies in Support of Special Populations: Geriatrics Questions & Answers ...

EMEA: Draft community herbal monograph

09.11.2009
Draft community herbal monograph on Cimicifugae rhizoma ...

EMEA: Updated inventory of herbal substances for assessment

09.11.2009
Inventory of herbal substances for assessment – Alphabetical order ...

EMEA: Updated community herbal monograph

09.11.2009
Updated community herbal monograph on: Salicis cortex Salix purpurea L.; Salix daphnoides Vill.; Salix fragilis L., cortex ...

FDA: Dosage Delivery Devices for OTC Liquid Drug Products

09.11.2009
This document is intended to provide guidance to firms that are manufacturing, marketing, or distributing over-the-counter (OTC) liquid drug products (e.g., elixirs, suspensions, solutions, ...

EMEA: QRD document update

06.11.2009
Translation of the statements for use in SmPC Section 4.6 \"Pregnancy and lactation\" as given in Appendix 3 to the \"Guideline on risk assessment of medicinal products on human reproduction and ...

EMEA: Concept paper on the revision of the guideline on Radiopharmaceuticals based on Monoclonal Antibodies

06.11.2009
The revision of the Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies will focus on quality aspects encompassing both monoclonal antibodies and radiopharmaceutical aspects and will ...

MHRA: European Commission review of the Clinical Trials Directive

06.11.2009
On 9 October 2009, the Commission published a public consultation document seeking comments on a range of questions posed. To ensure that in coming to a UK position we have taken account of the ...

EMEA: Concept paper on the need for revision of the CHMP note for guidance on the clinical development of medicinal products in the treatment of asthma

30.10.2009
The CHMP note for guidance on the clinical investigation of medicinal products in the treatment of asthma came into operation in May 2003. Since then, it has been proven to be useful for both ...

EMEA: EMEA post-authorisation procedural advice has been updated

30.10.2009
This guidance document addresses a number of questions which Marketing Authorisation Holders (MAHs) may have on post-authorisation procedures. It provides an overview of the EMEA position on ...