Drug Development Consultant and Regulatory Consultant

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Drug Regulators, EMEA, Publish Guidance on the Development of therapies for Cystic Fibrosis

CF is a life threatening and chronically debilitating disease, impairing the Quality of life, characterised by progressive bronchiectasis and obstructive pulmonary disease (> 90% patients).

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Twitter Weekly Updates for 2009-11-29

Market access issues are central to indication selction and central to market access is an understanding of the treatment pathways #
Wow the drug/biotech regulations change so quickley. Go to damienbove.com for our free regulatory watch service. #
Desk research in medical technologies from 350per day. Markets, deals, suppliers, liturature, people, companies, or anything you want #
We [...]

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Drug Regulators, FDA CDER, Publish Updated Guidance on Investigator Responsibilities for Study Subjects

This guidance provides an overview of the responsibilities of a person who conducts a clinical investigation of a drug, biological product, or medical device (an investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)).

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Drug Regulators, FDA (CDER), Publishes Guidance on SPL Standard for Content of Labeling Technical Qs & As

This guidance is intended to assist applicants who submit content of labeling to FDA as part of a marketing application using the structured product labeling standard (SPL) in extensible markup language (XML)

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Twitter Weekly Updates for 2009-11-22

DILI the FDA liver tox regulations take a pragmatic stance on liver tox. If your going to save your product you need our expert review #

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European Commission Publishes Assessment of the Functioning of the Clinical Trials Directive

This assessment would consider, in particular, various options for further improving the functioning of the Clinical Trials Directive with a view to remedy shortcomings and unintended negative consequences while taking the global dimension of clinical trials into account.

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Drug Regulator, EMEA, Publishes ICH Guidance on the use of Oncolytic Viruses

Oncolytic viruses (OV) were first observed in early clinical studies in patients with malignancies where tumour regressions were observed to coincide with viral infections or with live virus vaccinations.

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Liver Toxicity, FDA DILI Regulations Require Interpretation

Signs of liver toxicity from experimental results can mean that a project is killed or investors walk away, but this is often an inappropriate response. Liver toxicity is a highly complex issue and in an attempt to provide some light on the issue the FDA has recently published guidelines on Drug Induced Liver Injury (DILI). These guidelines set the regulatory standard and take a very pragmatic position on livertox and encourage industry to likewise take a pragmatic view.

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Drug Regulators, EMEA, Re-Publish Guidance on Special Populations Geriatrics

This guideline is directed principally toward new Molecular Entities that are likely to have significant use in the elderly, either because the disease intended to be treated is characteristically a disease of aging ( e.g., Alzheimer’s disease) or because the population to be treated is known to include substantial numbers of geriatric patients (e.g., hypertension)

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How much does the tax man owe you?

There is an R&D Tax Credit for you if you are;- Developing new products,new science, New Services,New Software, or Large Engineering projects? , SO don’t miss out.