Drug Development Consultant and Regulatory Consultant

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Twitter Weekly Updates for 2010-02-28

A comprahensive training package for those involved in healthcare technology commercialisation will be launched soon watch this space #
When thinking about medical devices marketing is so much more important than with drugs! Route to market needs to be in you development plan #
New business support website to be launched soon! Helping consultants profit maximise! #

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Drug Regulators, MHRA, Publish Consultation Document on ARM 65 Algopain-EZE 140MG Medicated Plaster, Request to Reclassify a Prodcut from POM to P

Consultation ARM 65 seeks your views on the reclassification from POM to P Algopain-eze 140 mg Medicated Plaster. The Reclassification Summary and Patient Information Leaflet as provided by the applicant company are displayed below

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Drug Regulators, EMA (EMEA), Publish draft guidance on Clinical Investigations in the Treatment of Diabetes Mellitus

Diabetes mellitus is a metabolic disorder characterised by the presence of hyperglycaemia due to defective insulin secretion, insulin action or both. The chronic hyperglycaemia of diabetes mellitus is associated with significant long term sequelae, particularly damage, dysfunction and failure of various organs – especially the kidney, eye, nerves, heart and blood vessels.

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Drug Regulators, EMEA (EMA), Publish a Concept Paper on the Need For Guidance on Clinical Investigations of Medicinal Products in the Treatment of Diabetes Mellitus

The current CHMP Note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus CPMP/EWP/1080/00 was adopted by the CHMP in November 2002. New aspects have emerged since then including:

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Twitter Weekly Updates for 2010-02-21

Choice of regulator for scientific advice is not as simple as it looks! Agencies that approve you CTA might not do you marketing license! #
Flexibility is key when dealing with regulators! #

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Drug Regulators, FDA, Publish Guidance For Industry on Content of a Compleate Submission for the Evaluation of Proprietary Names

This guidance describes for industry the information that FDA uses to evaluate proposed proprietary names for certain drugs, including biological products, under the traditional review process within the time frames set out in Prescription Drug User Fee Act (PDUFA IV) performance goals. The review clock for the performance review goals begins when the Agency receives a complete submission2 (see sections II. Background and III. PDUFA IV Goal Dates)

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Drug Regulators, EMEA, Publish Addendum to the Note for Guidance on Evaluation of Medicinal Products Indicated for the Treatment of Bacterial Infections

This addendum to the Note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CHMP/EWP 558/95 Rev 1) has been produced in response to recent advances in the development of agents intended for the treatment of disease due to Mycobacterium tuberculosis.

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Drug Regulators, EMEA, Publish an Overview of Comments Received on Draft Guidance on Clinical Investigations of Medicinal Products Used in Osteoarthritis

Interested party (Organisations or individuals) that commented on the draft Guideline as released for
consultation
Stakeholder
No.
Name of Organisation or individual
1 OARSI, Osteoarthritis Research Society International
2 USZ, Department of Rheumatology and Institute of Physical Medicine, University Hospital
of Zurich, Switzerland
3 AESGP, Association of the European Self-Medication Industry
4 EFPIA
5 GREES, Osteoarthritis section
6 EULAR

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Twitter Weekly Updates for 2010-02-14

Licensing can be simple when you proposition is simple and the technology is a fit with current activites, without that its challenging #
Keeping ontop of admin can be damed demanding but all too esential, its like taking time to learn new things! #
Herbal medicines are a very important part of the medicine cabinet! Our experts [...]

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Drug Regulators, EMEA, Publish Concept Paper on Need to Revise Points to Consider on the Clinical Investigation of Medicinal Products Other than NSAIDs in Rheumatoid Arthritis

Since 2003 this guideline has presented guidance for the clinical development of slow-acting anti-rheumatic medicinal products aiming at symptom- and/or structure-modification (e.g. DMARDs, biologics) for the treatment of rheumatoid arthritis (RA). In the last years efforts have been made in that field with regard to the development of new products with an improved efficacy profile and novel insights have been gained with respect to the assessment of disease activity, joint damage and disability.