Drug Development Consultant and Regulatory Consultant

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Twitter Weekly Updates for 2010-01-31

You can know more about clinical trial design then any man alive! But until you speak to the clinical staff and gage feasibilty, its nothing #
If the villigers are going around burning houses with an X on the door! Don't paint an X on you door, or even a Y, it looks too like a [...]

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Regulators Publish Guidance for Industry, Non Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization.

The purpose of this document is to recommend international standards for, and promote harmonization of, the nonclinical safety studies recommended to support human clinical trials of a given scope and duration as well as marketing authorization for pharmaceuticals. Harmonization of the guidance for nonclinical safety studies will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.

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Drug Regulators, EMEA, Publish Guidance on Herbal Medicinal Products, Test Materials for Genotoxicity

The ‘Community list of herbal substances , preparations and combinations thereof for use in traditional herbal medicinal products’ is established by the European Commission based on proposals from the Committee on Herbal Medicinal Products (HMPC), in accordance with Directive 2001/83/EC as amended. The list is being developed gradually through entries of structured information relating to individual herbal substances or preparations.

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Twitter Weekly Updates for 2010-01-24

I'v been writing an FDA orphan application all day! Just a minor point to clear up and submit! #

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Drug Regulators, FDA CDER, Publish Guidance to Pharmacies on Compounding Oral Suspension

This guidance provides recommendations to pharmacies on the advance compounding of Tamilfu oral suspension to provide multiple prescriptions. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.

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Drug Regulators, FDA, Publishes Guidance for IRBs, Clinical Investigators and Sponsors

This draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations.

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£70 million Boost for UK manufacturing (including Regenerative medicines)

The first three state of the art manufacturing research centres funded under a new £70M Government investment will be based at Southampton, Loughborough and Brunel universities, to help UK businesses develop the technology products of the future and underpin manufacturing growth, Business Secretary Lord Mandelson announced today.

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Device Regulators, MHRA, Publish Poster on Mattress Decontamination

The MHRA has received numerous reports of damaged covers and associated interior mattress contamination. Mattress covers can become damaged at any time during use or storage, for example from: needle stick; strike-through damage from sharp objects; abrasion during handling, transport or movement; inappropriate cleaning and decontamination procedures.

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Drug Regulators, EMEA, Publish Guidance on the Evaluation of Drugs for the Treatment of Gastroesophageal Reflux Disease

This guideline intends to address the EU regulatory position on the main topics of the clinical development of new medicinal products in the treatment of patients with gastroesphageal reflux disease (GERD).

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Drug Regulators, European Medicines Agency, Publish Concept Paper on Revision of the Notes for Guidance on Gene Transfer Medicinal Products

This Concept Paper proposes a revision of the Note for Guidance on the Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products (CPMP/BWP/3088/99) that came into effect in 2001.