MHRA: Publication of responses to consultation MLX 358 on European Commission proposals on information to patients

On 10 December 2008 the European Commission published a legislative proposal for the pharmaceutical industry to be able to communicate certain information on prescription medicines directly to ...

MHRA: Updates to BROMI guidance documents added to the Labels, patient information leaflets and packaging for medicines section

Two updated BROMI guidance documents have been added to the Labels, patient information leaflets and packaging for medicines section. MHRA guidance on changes to labelling and patient ...

FDA: E7 Studies in Support of Special Populations

Draft Guidance E7 Studies in Support of Special Populations: Geriatrics Questions & Answers ...

EMEA: Draft community herbal monograph

Draft community herbal monograph on Cimicifugae rhizoma ...

EMEA: Updated inventory of herbal substances for assessment

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

EMEA: Updated community herbal monograph

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

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

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

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

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 ...

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