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EMEA: Overview of comments received on the draft guideline on the development of New Medicinal Products for the Treatment of Smoking

19.11.2009
SRNT Europe, representing European scientists in the field of nicotine and tobacco research, is concerned that this guideline in its present form will be a barrier to the development of new ...

MHRA: MHRA Patient Information Quality Unit performance figures

19.11.2009
MHRA is now publishing performance figures for the Patient Information Quality Unit (PIQU).This follows feedback from the medicines trades associations that separate metrics are needed to aid ...

MHRA: Guidance published on UK exporting of medicines

19.11.2009
Guidance helping pharmaceutical manufacturers and distributors to meet their obligations about the supply of medicines, has been jointly published today by nine health organisations including the ...

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

19.11.2009
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

19.11.2009
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

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Draft Guidance E7 Studies in Support of Special Populations: Geriatrics Questions & Answers ...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

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